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Technical
Guide
Technical Information and Efficacy Data
TABLE OF CONTENTS
Hand Hygiene
PURELL® Instant Hand Sanitizer
PURELL Instant Hand Sanitizer with Aloe
PURELL Instant Hand Sanitizer Lasting Care Formula
PURELL Instant Hand Sanitizer with DERMAGLYCERIN SYSTEM™
PURELL Foaming Hand Sanitizer
PURELL Instant Hand Sanitizer Food Code Compliant
PROVON® Antimicrobial Skin Cleanser with 2% CHG
PROVON Medicated Lotion Soap with Chloroxylenol
PROVON Medicated Lotion Soap with Triclosan
PROVON Antimicrobial Lotion Soap with 0.3% Chloroxylenol
PROVON Gentle Lotion Soap
PROVON Mild Lotion Soap
PROVON Enriched Lotion Cleanser
PROVON Foaming Handwash with Moisturizers
PROVON Foaming Antimicrobial Handwash with Moisturizers and 0.3% Chloroxylenol
PROVON Foaming Medicated Handwash with Moisturizers and 0.5% Triclosan
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2
4
5
7
8
9
13
14
15
16
16
17
17
18
19
Bathing & Moisturizing
PROVON
PROVON
PROVON
PROVON
PROVON
PROVON
PROVON
PROVON
Antibacterial Body Wash
Moisturizing Bathing Cloths
Conditioning Shampoo & Body Wash
Tearless Shampoo & Body Wash
Enriched Shampoo for Body & Hair
Foaming Hair & Body Wash with Moisturizers
Moisturizing Hand & Body Lotion
Skin Moisturizer with Aloe & Vitamins
22
23
24
24
25
25
26
27
Perineal Skin Care
PROVON
PROVON
PROVON
PROVON
PROVON
PROVON
Perineal Wash
Antibacterial Perineal Wash
Personal Wash Cloths
Moisturizing Perineal Skin Protectant with Petrolatum
Perineal Cream
Perineal Ointment with Petrolatum
27
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30
Glossary of Terms
Glossary of Terms
Inside Back Cover
Hand Hygiene
PURELL® Instant Hand Sanitizer
Efficacy Data — In Vitro
Dermatologist-tested, dye-free. Latex compatible.
CHG compatible.
Objective: These tests were designated to
evaluate the antimicrobial effectiveness of product formulations when challenged with a broad
spectrum of microorganisms.
Description of Test: Fifteen (15) second
exposure kill studies were performed utilizing thirtyfour (34) challenge microorganisms. The challenge
inoculum was introduced to the test product at time
zero; a portion of the sample was removed and
placed in neutralizing media at the appropriate time
(15 seconds). Standard plate counting techniques
were used to enumerate viable challenge
micro-organisms.
Independent Laboratories:
BioScience Laboratories,
Bozeman, Montana; November 3, 1999; March 9,
1998. February 9, 2001.
Stock No. 9651, 9652, 9654, 9656, 9657, 9659, 9661, 7187,
2256, 2156, 9605, 9606, 3020, 9584, 3005, 9650
Physical Characteristics
Color: Clear
Fragrance: Citrus
Viscosity: 6,000-25,000 cps (gel)
pH: 4.5-9.5
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay.
Method: The method is that summarized by Phillips
et al. (Toxic and Applied Pharmacology 21:369-382,
1972). The fresh materials are applied five (5) days weekly
for twenty-one (21) days to the same site. Patches are not
reapplied on weekends (or holidays); they remain in place
for these periods. There are fifteen (15) days of reading,
even when holidays intervene.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: February 27, 1998
Results: Average score 0.05 (scale 0-4). Lower scores
indicate lower potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Percent Reduction of Test Organisms After
a 15-Second Exposure
Human Repeated Insult Patch Test
Objective: Determination of the dermal irritation and
sensitization potential of the product.
Description of Test: Human repeated patch test.
Method: This study was conducted utilizing a
standard protocol and a total of two hundred and
fifteen (215) subjects. Prior to patch application, the test
area was wiped with seventy percent (70%) ethanol and
allowed to dry. The test material was applied under a
semi-occlusive patch (Readi-Bandage®) to the upper
back (between the scapulae) and allowed to remain in
direct skin contact for twenty-four (24) hours. Patches
were applied to the same site on Monday, Wednesday
and Friday for a three (3)-week induction period. The sites
were graded for
dermal irritation and sensitization twenty-four (24)
hours after removal of the patches on Tuesday and
Thursday, and forty-eight (48) hours after patch removal
on Saturday. Standard Dermal Scores (0-4+) were used
to record dermal reactions. After two (2) weeks, the subjects were rechallenged and evaluated forty-eight (48) and
seventy-two (72) hours after
patch removal.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, New Jersey.
Date: April 30, 2002
Results: No dermal reactions were observed during the
induction or challenge phases of the study.
Conclusion: Test product did not demonstrate potential
for eliciting a dermal irritation or sensitization.
Microorganism
ATCC No.
% Reduction
Acinetobacter baumannii
Bacillus megaterium
Citrobacter freundii
Clostridium difficile
Corynebacterium
diphtheriae
Enterobacter aerogenes
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Escherichia coli
(O157; H7)
Klebsiella ozaenae
Klebsiella pneumoniae
Lactobacillus plantarum
Listeria monocytogenes
Proteus mirabilis
Proteus vulgaris
Pseudomonas aeruginosa
Salmonella enteritidis
Salmonella typhimurium
Serratia marcescens
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
Methicillin resistant
Staphylococcus aureus
Vancomycin intermediate
Methicillin resistant
Staphylococcus
epidermidis
Streptococcus
pneumoniae
Streptococcus pyogenes
19606
14581
8090
9689
>99.999
>99.998
>99.999
99.998
11913
13048
>99.999
>99.999
51575
>99.999
51559
11229
>99.999
>99.999
35150
11296
13883
14917
15313
7002
13315
15442
13076
14028
14756
13313
11060
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
33591
>99.999
Clinical Isolate >99.999
12228
>99.999
33400
19615
99.994
>99.999
9643
9642
14053
13803
52063
9849
9533
>99.999
>99.998
>99.999
>99.999
>99.988
>99.999
>99.999
Yeasts and Fungi
Aspergillus flavus
Aspergillus niger
Candida albicans
Candida tropicalis
Epidermophyton floccosum
Penicillium citrinum
Trichophyton metagropytes
Conclusion: Very effective reduction of
Gram-negative and Gram-positive bacteria, yeasts,
and fungi was demonstrated.
1
PURELL® Instant Hand Sanitizer
(continued)
PURELL® Instant Hand Sanitizer with Aloe
Efficacy Data — In Vitro Virus Test
Description of Test: A suspension of
challenge virus was exposed to product. An
aliquot was removed and neutralized at the 30second exposure by serial dilution and then
assayed for the presence of viable virus. The
following controls were assayed in parallel:
positive virus, cytotoxicity, and neutralization.
Independent Test Laboratory:
ViroMed Laboratories, Inc.,
Minneapolis, Minnesota; April 29, 1998;
September 23, 1998, November 4, 1998.
Dermatologist-tested. Latex compatible. CHG compatible.
Percent Reduction of Test Organisms
After a 30-Second Exposure
Irritancy Data and Allergy Test Results
Microorganism
Adenovirus type 2
Coxsackievirus B3
Hepatitis A Virus
Herpes Simplex Virus
Type 1
HIV type 1
Influenza Virus
Type A2
Parainfluenza Virus
Type 2
Parainfluenza Virus
Type 3
Rhinovirus Type 14
Rhinovirus Type 16
Rhinovirus Type 37
** Variant 18F
ATCC No.
VR-846
VR-30
VR-1073**
Stock No. 9637, 9631, 9639, 2237, 2137, 9682, 9641
Physical Characteristics
Color: Clear, Green
Fragrance: Pleasant Floral
Viscosity: 6,000-25,000 cps (gel)
pH: 4.5-9.5
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Cumulative Irritancy.
Method: The method is that summarized by Phillips et
al. (Toxic and Applied Pharmacology 21:369-382,
1972). The fresh materials are applied five (5) days weekly for twenty-one (21) days to the same site. Patches are
not reapplied on weekends (or holidays); they remain in
place for these periods. There are
fifteen (15)
days of reading, even when holidays
intervene.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 5, 2002
Results: Average scores 0.06 (Scale 0-4)
Conclusion: Product has a very low potential for eliciting skin irritation and allergic contact dermatitis.
% Reduction
95.195
99.822
94.377
VR-733
HTLV-IIIB
≥99.999
≥99.993
VR-544
≥99.999
VR-92
≥99.996
VR-93
VR-284
VR-1126
VR-1147
≥99.993
99.438
≥99.994
99.822
Human Repeated Insult Patch Test
Ingredients
Active Ingredient
Ethyl Alcohol 62%
Also Contains:
Water
Carbomer
Tocopheryl Acetate
(Vitamin E)
Glycerin
Propylene Glycol
Isopropyl Myristate
Aminomethyl Propanol
Fragrance
Objective: Evaluation of skin irritation and
sensitization potential in humans.
Description of Test: Human repeated insult patch
test.
Method: This study was conducted utilizing a
standard protocol and a total of one hundred and four
(104) subjects. Prior to patch application, the test area
was wiped with seventy percent (70%) ethanol and
allowed to dry. The test material was applied under a
semi-occlusive patch (Readi-Bandage®) to the upper
back (between the scapulae) and allowed to remain in
direct skin contact for twenty-four (24) hours. Patches
were applied to the same site on Monday, Wednesday
and Friday for a three (3)-week induction period. The
sites were graded for dermal irritation and sensitization
twenty-four (24) hours after removal of the patches on
Tuesday and Thursday, and forty-eight (48) hours after
patch removal on Saturday. Standard Dermal Scores
(0-4+) were use
to record dermal reactions. After two (2) weeks, the
subjects were rechallenged and evaluated forty-eight
(48) and seventy-two (72) hours after patch removal.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, New Jersey.
Date: September 10, 1997
Results: No observed dermal reactions.
Conclusion: No demonstrated potential for eliciting
dermal irritation or sensitization.
Ingredient Class
Antimicrobial Agent
Diluent
Thickener
Skin Conditioning Agent
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent,
Humectant
Emollient
pH Adjuster
Fragrance
2
PURELL® Instant Hand Sanitizer with Aloe
(continued)
Efficacy Data — In Vitro
Ingredients
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15) second
exposure kill studies were performed utilizing
twelve (12) challenge bacteria. The challenge inoculum
was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds).
Standard plate counting techniques were used to enumerate viable challenge
microorganisms.
Independent Lab: BioScience Laboratories, Inc.,
Bozeman, Montana
Independent Test Labortory, Minneapolis, Minn.
Date: September 8, 1997
Active Ingredient
Ethyl Alcohol 62%
Also Contains:
Water
Glycerin
Carbomer
Fragrance
Aloe Barbadensis
Leaf Juice
Aminomethyl Propanol
Propylene Glycol
Isopropyl Myristate
Tocopheryl Acetate
Yellow No. 5
Blue No. 1
Percent Reduction of Test Organisms after a
15-Second Exposure
Microorganism
ATCC No.
Clostridium difficile
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Listeria monocytogenes
Pseudomonas
aeruginosa
Salmonella typhimurium
Serratia marcescens
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
Streptococcus pyogenes
9689
% Reduction
99.99
51575
>99.99
51559
11229
7644
>99.99
>99.99
>99.99
15442
14028
14756
13313
11060
6538
19615
>99.99
>99.99
>99.99
>99.99
>99.99
>99.99
>99.99
Conclusion: Very effective reduction of
Gram-negative and Gram-positive bacteria
was demonstrated.
3
Ingredient Class
Antimicrobial Agent
Diluent
Skin Conditioning Agent,
Humectant
Thickener
Fragrance
Botanical Additive, Skin
Conditioning Agent
pH Adjuster
Skin Conditioning Agent,
Humectant
Emollient
Skin Conditioning Agent
Colorant
Colorant
Human Repeated Insult Patch Test (continued)
PURELL® Instant Hand Sanitizer Lasting Care Formula
Dermatologist-tested. Latex compatible.
Independent Laboratory: Clinical
Research Laboratories, Inc. Piscataway,
New Jersey.
Date: October, 1999.
Results: No dermal reactions were observed
during the induction or challenge phases of
the study.
Conclusion: Test product demonstrated no clinically
significant potential for eliciting either dermal irritation or
sensitization.
Stock No. 9671, 9672, 2176
Physical Characteristics
Color: Clear
Fragrance: Citrus
Viscosity: 6,000-25,000 cps
pH: 4.5 - 9.5
Irritancy Data and Allergy Test Results
Efficacy Data-- In Vitro
Objective: Evaluation of skin irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Method: The method is that summarized by Phillips
et al. (Toxic and Applied Pharmacology 21:369-382,
1972). The fresh materials are applied five (5) days weekly
for twenty-one (21) days to the same site. Patches are
not reapplied on weekends (or holidays); they remain in
place for these periods. There are fifteen (15) days of
reading, even when holidays intervene.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 12, 1998
Results: No dermal reactions were observed
during the induction or challenge phases of the study.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15)-second
exposure kill studies were performed using
twenty-five (25) challenge microorganisms.
The challenge inoculum was introduced to
the test product at time zero; a portion of the
sample was removed and placed in neutralizing
media at the appropriate time (15 seconds).
Standard plate counting techniques were used to
enumerate viable challenge microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: September, 1999.
Percent Reduction of Test Organisms After a
15-Second Exposure
Human Repeated Insult Patch Test
Objective: Determination of the dermal irritation
and sensitization potential of the product.
Description of Test: Human repeated insult
patch test.
Method: This study was conducted utilizing a total
of two hundred twenty one (221) subjects. The test
material was applied under a semi-occlusive patch
to the upper back and allowed to remain in direct
skin contact for twenty-four (24) hours. Patches were
applied to the same site on Monday, Wednesday,
and Friday for a three (3)-week induction period. The
`sites were graded for dermal irritation and sensitiza
tion twenty-four (24) hours after removal of the patches
on Tuesday and Thursday, and forty-eight (48)
hours after patch removal on Saturday. Standard
Dermal Scores (0-4+) were used to record dermal
reactions.
Microorganism
ATCC No. % Reduction
Acinetobacter baumannii
Bacillus megaterium
Citrobacter freundii
Clostridium difficile
Corynebacterium
diphtheriae
Enterobacter aerogenes
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Escherichia coli
(O157; H7)
Klebsiella ozaenae
Klebsiella pneumoniae
Lactobacillus plantarum
Listeria monocytogenes
Proteus mirabilis
Proteus vulgaris
Pseudomonas aeruginosa
Salmonella enteritidis
Salmonella typhimurium
Serratia marcescens
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
Methicillin resistant
Staphylococcus
epidermidis
Streptococcus pyogenes
19606
14581
8090
9689
>99.999
>99.996
>99.999
>99.999
11913
13048
>99.999
>99.999
51575
>99.999
51559
11229
>99.999
>99.999
35150
11296
13883
14917
15313
7002
13315
15442
13076
14028
14756
13313
11060
>99.999
>99.999
>99.999
>99.996
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
33591
>99.999
12228
19615
>99.999
>99.999
Conclusion: Very effective reduction of
Gram-negative and Gram-positive bacteria
was demonstrated.
4
PURELL® Instant Hand Sanitizer Lasting Care Formula
(continued)
PURELL® Instant Hand Sanitizer
with DERMAGLYCERIN SYSTEM™
Persistence Data
Dermatologist-tested. Latex compatible. Vinyl compatible.
Nitrile compatible. CHG compatible.
Objective: Evaluate the persistent antibacterial
efficacy of the product on the skin.
Description of Test: Persistent antimicrobial
efficacy of the product was performed by
measuring the inhibition of a marker microorganism
(Staphylococcus aureus ATCC #6538) on an agar
plate following exposure to forearm skin. Twelve
subjects were randomly assigned to the control
group in which no product was applied to the
forearm skin. Ten subjects each were randomly
assigned to one of the two post-application intervals
(4-hour and 6-hour). The marker organism plates
were applied to the volar forearms of the subjects for
a total of 30 minutes. The agar plates were incubated
at 30°C for 24-48 hours.
Independent Laboratory: BioScience Laboratory
Inc., Bozeman, MT
Date: September 27, 1999.
Conclusion: The product resulted in significant
inhibition of the marker microorganism after 4-hour
and 6-hour post product application.
Stock No. 9648, 9691, 9646, 2151
Physical Characteristics
Active Ingredient: 62% Ethyl Alcohol
Color: White opaque solution
Fragrance: Mild alcohol odor with herbal fragrance
Form: Liquid
pH: 4.5-9.5
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Method: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the
method utilized for this evaluation. Fresh materials
are applied daily, 5 days per week, for 21 days to
the same site (patches were not moved or
reapplied on the weekends).
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, CA
Date: 26 July 2004
Results: Average Score = 0.06 (scale 0-4); No
sensitization occurred.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Efficacy Data — In Vivo
Objective: This study evaluated the antimicrobial
effectiveness of one (1) test products and one (1) reference product using a Healthcare Personnel Handwash
Procedure, as per methodology specified by the Food
and Drug Administration (FR 59:116, 17 June 94, pp.
31448-31450).
Description of Test: The antimicrobial effectiveness
of one (1) test product and one (1) reference product
for use as Health Care Personnel Handwashes was
determined using ten (10) consecutive hand contamination/product application procedures. Serratia
marcescens (ATCC #14756) was the marker organism
used for hand contaminations. Eighteen (18) human
subjects were utilized for the test and referenced product, for a total of thirty-six (36) subjects. Microbial samples were taken at baseline and after washes one (1),
three (3), seven (7), and ten (10). All sampling of the
hands was performed using the Glove Juice Sampling
Procedure. The testing methods were based on the
Food and Drug Administration Tentative Final
Monograph (TFM) for Effectiveness Testing of an
Antiseptic Handwash or Health Care Personnel
Handwash (FR 59:116, 17 June 94, pp. 3144831450).
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, MT
Date: June 24, 2004
Results:
Wash
Reduction from
Number
Baseline
Log10
Ingredients
Active Ingredient
Ingredient Class
Ethyl Alcohol 62%
Antimicrobial Agent
Also Contains:
Water (Aqua)
Glycerin
Isopropyl Myristate
Propylene Glycol
Retinyl Palmitate
Tocopheryl Acetate
Zea Mays (Corn Oil)
Acrylates/C10-30 Alkyl
Acrylate Crosspolymer
Aminomethyl Propanol
Fragrance (Parfum)
Triclosan
Diluent
Skin Conditioning
Agent, Humectant
Emollient
Skin Conditioning Agent,
Humectant
Skin Conditioning
Agent
Skin Conditioning
Agent
Skin Conditioning
Agent
Thickener
1
3
7
10
pH Adjuster
Fragrance
Preservative
5
3.33
3.75
3.59
3.17
PURELL® Instant Hand Sanitizer
with DERMAGLYCERIN SYSTEM
(continued)
Challenge Microbe
Conclusions: Test product produced statistically
significant (p < 0.05) Log10 reductions in bacterial
populations from baseline populations of 3.33 after
Wash 1 and 3.17 after Wash 10. The critical indices of
this study were a two (2) Log10 reduction after Wash
1 and a three (3) Log10 reduction after Wash 10. The
test product met these criteria.
ATCC No.
Staphylococcus aureus
Staphylococcus aureus
(MRSA)
Staphylococcus aureus
(VIMRSA)
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus
saprophyticus
Streptococcus pneumoniae
Streptococcus pyogenes
Efficacy Data-- In Vitro
Objective: Evaluate the antimicrobial effectiveness
of the product in vitro.
Description of Test: Fifteen (15) second exposure
kill evaluations were performed utilizing forty two (42)
challenge bacterial strains. The challenge inoculum
was introduced to the test product at time zero; a
portion of the sample was removed and placed in
neutralizing media at the appropriate time
(15 seconds). Standard plate counting techniques
were used to enumerate viable challenge
microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: June 23, 2004.
Yeasts and Fungi
29213
33591
>99.9999
>99.9999
042800VISA* >99.9999
12228
43253
29885
49453
>99.9999
>99.9999
>99.9999
>99.9999
33400
19615
>99.9993
>99.9999
ATCC No.
Aspergillus flavus
Aspergillus niger
Candida albicans
Candida tropicalis
Epidermophyton floccosum
Penicillium citrinum
Trichophyton mentagrophytes
% Reduction
9643
9642
14053
13803
52063
9849
9533
% Reduction
>99.9999
>99.3984
>99.9999
>99.9999
>99.9895
>99.9995
>99.9997
VISA - Vanncomycin-Intermediate Staphylococcus aureus
MRSA - Methicillin-Resistant Staphylococcus aureus
*=BSLI Clinical Isolate number
Conclusion: Very effective reduction of
Gram-negative and Gram-positive bacteria, yeasts
and fungi was demonstrated.
Percent Reduction of Test Organisms after a
15-Second Exposure
Challenge Microbe
ATCC No.
% Reduction
Ingredients
Acinetobacter baumannii
Bacillus megaterium
Bacteroides fragilis
Campylobacter jejuni
Citrobacter freundii
Clostridium difficile
(vegetative cells)
Clostridium perfringens
(vegetative cells)
Corynebacterium diphtheriae
Enterobacter aerogenes
Enterococcus faecalis (VRE)
Enterococcus faecalis
Enterococcus faecium (VRE)
Escherichia coli
Escherichia coli
Escherichia coli (O157:H7)
Haemophilus influenzae
Klebsiella pneumoniae
Subsp.ozaenae
Klebsiella pneumoniae
Subsp.pneumoniae
Lactobacillus plantarum
Listeria monocytogenes
Listeria monocytogenes
Micrococcus luteus
Proteus mirabilis
Proteus vulgaris
Pseudomonas aeruginosa
Pseudomonas aeruginosa
Salmonella choleraesuis
Serotype Choleraesuis
Salmonella choleraesuis
Serotype Enteritidis
Salmonella choleraesuis
Serotype Typhimurium
Serratia marcescens
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
19606
14581
29762
29428
8090
9689
>99.9999
>99.9985
>99.9999
>99.9999
>99.9998
>99.9999
Active:
13124
>99.9912
11913
13048
51575
29212
51559
11229
25922
35150
33930
11296
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9998
>99.9998
>99.9999
>99.9999
13883
>99.9999
14917
7644
15313
7468
7002
13315
15442
27853
10708
>99.9999
>99.9999
>99.9999
>99.9997
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
13076
>99.9999
14028
>99.9999
14756
13313
11060
6538
>99.9999
>99.9999
>99.9999
>99.9999
INCI Name*
Ingredient Class
Ethyl Alcohol 62%
Antimicrobial Agent
Also Contains:
Water (Aqua)
Cyclomethicone
Cetearyl Isononanoate
Propylene Glycol
Carbomer
Styrene/Acrylates Copolymer
Glycerin
Cetyl Lactate
Diazolidinyl Urea
Aminomethyl Propanol
C12-15 Alkyl Benzoate
Methylparaben
Fragrance (Parfum)
PEG-4
Propylparaben
Iodopropynyl Butylcarbamate
Tocopheryl Acetate
Cacamidopropyl PGDimonium Chloride Phosphate
Carrier
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
Viscosity Increasing Agent
Viscosity Increasing Agent
Skin Conditioning Agent
Skin Conditioning Agent
Preservative
pH adjuster
Skin Conditioning Agent
Preservative
Fragrance
Solvent
Preservative
Preservative
Skin Conditioning Agent
Conditioning Agent
*International Nomenclature Cosmetic Ingredient
6
Efficacy Data — In Vivo
PURELL® Foaming Hand Sanitizer
Dermatologist-tested. Product meets the Protocol for Healthcare
Personnel Handwash. Latex compatible. CHG compatible.
Healthcare Personnel Handwash Data
Objective: This study evaluated the antimicrobial
effectiveness of one (1) test product and one (1) reference product using a Healthcare Personnel Handwash
Procedure, as per methodology specified by the Food
and Drug Administration (FR 59:116, 17 June 94, pp.
31448-31450).
Description of Test: The antimicrobial effectiveness
of one (1) test product and one (1) reference product
for use as Health Care Personnel Handwashes was
determined using ten (10) consecutive hand contamination/product application procedures. Serratia
marcescens (ATCC #14756) was the marker organism
used for hand contaminations. Eighteen (18) human
subjects were utilized for the test and referenced product, for a total of thirty-six (36) subjects. Microbial samples were taken at baseline and after washes one (1),
three (3), seven (7), and ten (10). All sampling of the
hands was performed using the Glove Juice Sampling
Procedure. The testing methods were based on the
Food and Drug Administration Tentative Final
Monograph (TFM) for Effectiveness Testing of an
Antiseptic Handwash or Health Care Personnel
Handwash (FR 59:116, 17 June 94, pp. 3144831450). Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, MT
Date: January 22, 2003
Results:
Wash
Reduction from
Number
Baseline
Log10
Stock No. 9698
Physical Characteristics
Active Ingredient: 62% Ethyl Alcohol
Color: White foam
Fragrance: Mild alcohol odor
Form: Foam
pH: 7.0-8.0
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: 21 Day Cumulative Irritancy
Assay with Challenge. Fresh materials are applied
daily, 6 days per week, for 21 days to the same site
(patches were not moved or reapplied on Sunday).
Independent Laboratory: RCTS, Inc., Irving, TX
Date: January 3, 2003
Results: Average Score = 0.02 (scale 0 – 4); No
sensitization occurred.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Human Repeated Insult Patch Test
1
3
7
10
Objective: Determination of the dermal irritation and
sensitization potential of the product.
Description of Test: Human repeated insult patch test.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, New Jersey.
Date: February 25, 2003
Results: No visible skin reactions were observed during
the induction or challenge phases of the study.
Conclusion: Test product demonstrated no potential for
eliciting either dermal irritation or sensitization.
Conclusions: Test product produced statistically significant (p < 0.05) Log10 reductions in bacterial populations from baseline populations of 3.29 after Wash 1
and 3.12 after Wash 10. The critical indices of this
study were a two (2) Log10 reduction after Wash 1
and a three (3) Log10 reduction after Wash 10. The
test product met these criteria.
Ingredients
INCI Name*
Ingredient Class
Ethyl Alcohol 62%
Antimicrobial Agent
Active:
Also Contains:
Water (Aqua)
Hydrofluorocarbon 152a
Isobutane
Emulsifying Wax NF
Cetyl Lactate
Steareth-2
Propane
Sodium Benzoate
Sodium Sesquicarbonate
Fragrance (Parfum)
3.29
2.82
2.95
3.12
Carrier
Propellant
Propellant
Stabilizer
Emollient
Emulsifying Agent
Propellant
Fragrance Ingredient
pH adjuster
Fragrance
*International Nomenclature Cosmetic Ingredient
7
PURELL® Foaming Hand Sanitizer
(continued)
PURELL® Instant Hand Sanitizer Food Code Compliant
Efficacy Data — In Vitro
Dermatologist-tested. Latex compatible.
Timed-Exposure Kill Tests
Objective: Evaluate the antimicrobial effectiveness
of the product in vitro.
Description of Test: Fifteen (15) or thirty (30) second exposure kill evaluations were performed utilizing
twenty-seven (27) challenge bacterial strains. The
challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed
and placed in neutralizing media at the appropriate
time (15 or 30 seconds). Standard plate counting
techniques were used to enumerate viable challenge
microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: January 28, 2003.
Stock No. 2166, 9666, 2006, 9660
Physical Characteristics
Active Ingredient: 62% Ethyl Alcohol
Color: Clear to hazy solution
Fragrance: Mild alcohol odor with lemon fragrance
Form: Liquid
pH: 4.5-9.5
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Method: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the
method utilized for this evaluation. Fresh materials
are applied daily, 5 days per week, for 21 days to
the same site (patches were not moved or reap
plied on the weekends).
Independent Laboratory: RCTS, Inc. Irving, Texas
Date: January 3, 2003
Results: Average Score = 0.05 (scale 0-4); No
sensitization occurred.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Results: Percent Reduction of Test Organisms After
a 15-Second Exposure
Challenge Microbe ATCC No.
Acinetobacter
19606
baumannii
Campylobacter jejuni
29428
Citrobacter freundii
8090
Clostridium difficile
9689
Corynebacterium
11913
diphtheriae
Enterobacter aerogenes
13048
Enterococcus faecalis
51575
(VRE)
Enterococcus faecium
51559
(VRE)
Escherichia coli
11229
Escherichia coli (O157:H7) 35150
Klebsiella pneumoniae
11296
Subsp.ozaenae
Klebsiella pneumoniae
13883
Subsp.pneumoniae
Lactobacillus plantarum
14917
Listeria monocytogenes
15313
Proteus mirabilis
7002
Proteus vulgaris
13315
Pseudomonas aeruginosa 15442
Salmonella choleraesuis
13076
Serotype Enteritidis
Salmonella choleraesuis
14028
Serotype Typhimurium
Serratia marcescens
14756
Shigella dysenteriae
13313
Shigella sonnei
11060
Staphylococcus aureus
33591
(MRSA)
Staphylococcus aureus
03230
(MRSA)
1MMRSa4*
Staphylococcus
12228
epidermidis
Streptococcus pneumoniae 33400
Streptococcus pyogenes
19615
% Reduction
>99.9999
>99.9995
>99.9999
>99.9999
>99.9998
>99.9993
>99.9999
Efficacy Data-- In Vitro
>99.9999
Objective: Evaluate the antimicrobial effectiveness
of the product in vitro.
Description of Test: Fifteen (15)-second
exposure kill evaluations were performed utilizing
twelve (12) challenge bacterial strains.
The challenge inoculum was introduced to
the test product at time zero; a portion of the
sample was removed and placed in neutralizing
media at the appropriate time (30 seconds).
Standard plate counting techniques were used to
enumerate viable challenge microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: January 9, 2003.
>99.9999
>99.9998
>99.9999
>99.9999
>99.9998
>99.9999
>99.9999
>99.9983
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
>99.9999
*Clinical Isolate
MRSA - Methicillin-Resistant Staphylococcus aureus
8
PURELL® Instant Hand Sanitizer Food Code Compliant
(continued)
Percent Reduction of Test Organisms After a
30-Second Exposure
Microorganism
ATCC No. % Reduction
Acinetobacter baumannii
Candida albicans
Enterobacter cloacae
Enterococcus faecium
Escherichia coli
Klebsiella pneumoniae
Micrococcus luteus
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus
epidermidis
19606
10231
13047
51559
25922
11296
7468
7002
27853
14756
29213
12228
PROVON® Antimicrobial Skin Cleanser with 2% CHG
Dermatologist-tested. Meets protocol for Healthcare Personnel
Handwash, Surgical Scrub, Pre-Operative Skin Prep, PreInjection Skin Prep & Wound Cleanser.
Latex Compatible.
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
Stock No. 4106, 4104
Physical Characteristics
Color: Clear Colorless to Clear Pink
Fragrance: Floral
Viscosity: 1,000-4,000 cps
pH: 4.50-6.80
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: October 17, 1997
Results: Average score 0.06 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Ingredients
Active Ingredient
Ethyl Alcohol 62%
Also Contains:
Water (Aqua)
Carbomer
Glycerin
Fragrance (Parfum)
Sodium Hydroxide
Propylene Glycol
Trocopheryl Acetate
Ingredient Class
Antimicrobial Agent
Carrier
Viscosity Increasing Agent
Skin Conditioning Agent
Fragrance
pH Adjuster
Skin Conditioning Agent
Skin Conditioning Agent
Efficacy Data — In Vitro
Timed-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen(15)-second-exposure kill
studies were performed utilizing eighteen (18) challenge bacterial strains. The challenge inoculum was
introduced to the test product at time zero;
a portion of the sample was removed and placed
in neutralizing media at the appropriate time
(15 seconds). Standard plate counting techniques were
used to enumerate viable challenge
micro-organisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: September 23, 1997
9
PROVON® Antimicrobial Skin Cleanser
with 2% CHG (continued)
Efficacy Data — In Vitro (continued)
Percent Reduction of Test Organisms
After a 15-Second Exposure
Microorganism
ATCC No.
% Reduction
Clostridium difficile
Enterococcus faecalis
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Escherichia coli
(O157; H7)
Klebsiella ozaenae
Listeria monocytogenes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella typhimurium
Serratia marcescens
Shigella sonnei
Staphylococcus aureus
Staphylococcus aureus
Methicillin resistant
Staphylococcus
epidermidis
Streptococcus pyogenes
9689
19433
>99.999
>99.999
51575
19434
>99.999
>99.999
51559
11229
>99.999
>99.999
35150
11296
7644
7002
15442
14028
14756
11060
6538
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
>99.999
33591
>99.999
14990
19615
>99.999
>99.999
Efficacy Data — MICs
Minimum Inhibitory Concentrations (MICs)
Objective: Demonstration of the broad spectrum of
antimicrobial activity.
Description of Test: Bacterial tests run with agar to
determine the concentration of chlorhexidine
gluconate required to inhibit growth.
Reference: Graham W. Denton, Disinfection,
Sterilization and Preservation, Lea & Febiger, Malver,
Pennsylvania, 1991, Chapter 16, “Chlorhexidene,” p.
278-279.
Results: The minimum inhibitory concentrations
(MICs) of chlorhexidine gluconate are listed in
parts per million (ppm). Numbers in parentheses refer
to the number of strains evaluated.
Conclusion: Very effective reduction of Gram- negative and Gram-positive bacteria by the product
was demonstrated.
Efficacy Data — In Vivo
Microorganism
Bacteria (Number of Strains)
Micrococcus flavus (1)
Micrococcus lutea (1)
Staphylococcus aureus (16)
Staphylococcus epidermidis (41)
Streptococcus faecalis (5)
Streptococcus mutans (2)
Streptococcus pneumoniae (5)
Streptococcus pyogenes (9)
Streptococcus sanguis (3)
Streptococcus viridans (5)
Bacillus cereus (1)
Bacillus subtilis (2)
Clostridium difficile (7)
Clostridium welchii (5)
Corynebacterium sp. (8)
Lactobacillus casei (1)
Listeria monocytogenes (1)
Propionibacterium acne (2)
Acinetobacter anitratus (3)
Acinetobacter lwoffi (2)
Alcaligenes faecalis (1)
Bacteroides disastonis (4)
Bacteroides fragilis (11)
Campylobacter pyloridis (5)
Citrobacter freundii (10)
Enterobacter cloacae (12)
Escherichia coli (14)
Gardnerella vaginalis (1)
Haemophilus influenza (10)
Klebsiella aerogenes (5)
Klebsiella oxytoca (2)
Klebsiella pneumoniae (5)
Proteus mirabilis (5)
Proteus morganii (5)
Healthcare Personnel Handwash Data
Objective: Evaluation of the antimicrobial
effectiveness of the product on hands.
Description of Test: This study evaluated both the
immediate and persistent antimicrobial effects of the
product over the course of ten (10) consecutive microbial contamination/product application cycles. The
study utilized six (6) subjects for the product
and six (6) subjects for the control. The protocol
used was a modification of the ASTM Standard Method
and the methods described in the “Tentative Final
Monograph for Health-Care Antiseptic Drug Products,
Proposed Rule,” Federal Register, 59,
No. 116, 31448-31450, 1994. This procedure involves
determination of the reduction in transient bacteria on
the hands determined by the Glove Juice Technique
after Serratia marcescens contamination.
Independent Laboratory: North American Science
Associates, Inc., Northwood, Ohio.
Date: February 28, 1986
Results: Reductions in recoverable Serratia
marcescens counts.
Summary: Both products demonstrated a good rate
of kill and good residual activity throughout the course
of this study.
10
MICs (ppm)
0.5
0.5
1-4
0.25-8
32-64
2.5
8-16
1-8
4-16
2-32
8
1
8-32
4-32
0.5-8
128
4
8
16-64
0.5
64
16
8-64
8-32
4-32
16-64
2-32
8
2-8
16-64
32
32-128
64->128
16-128
PROVON® Antimicrobial Skin Cleanser
with 2% CHG (continued)
Efficacy Data — MICs (continued)
Surgical Scrub Evaluation
Microorganism
Bacteria (Number of Strains)
Proteus vulgaris (5)
Providencia stuartii (5)
Pseudomonas aeruginosa (15)
Pseudomonas cepacia (1)
Pseudomonas fluorescens (1)
Salmonella bredeney (1)
Salmonella dublin (1)
Salmonella galinarum (1)
Salmonella montevideo (1)
Salmonella typhmurium (4)
Salmonella virchow (1)
Serratia marcescens (10)
MICs (ppm)
Yeasts and Fungi
Aspergillus flavus (1)
Aspergillus fumigatus (1)
Aspergillus niger (1)
Penicillium notatum (1)
Rhizopus sp. (1)
Scopulariopsis sp. (1)
Candida albicans (2)
Candida guillermondii (1)
Candida parapsilosis (2)
Candida pseudotropicalis (1)
Cryptococcus neoformans (1)
Prototheca zopfii (1)
Saccharomyces cerevissia (1)
Torulopsis glabrata (1)
Epidermophyton floccosum (1)
Microsporum canis (2)
Microsporum fulvum (1)
Microsporum gypseum (1)
Trichophyton equinum (1)
Trichophyton interdigitale (2)
Trichophyton mentagrophytes (1)
Trichophyton quinkeanum (1)
Trichophyton rubrum (2)
Trichophyton tonsurans (1)
MIC (ppm)
64
32
16
16
8
8
9
4
4
3
1
6
1
6
4
4
6
6
4
3
3
3
3
3
Objective: This evaluation measures the immediate
and persistent antimicrobial effectiveness of the
product and a reference product.
Description of Test: Thirty-six (36) subjects
were recruited and completed this evaluation. Baseline
counts of the microbial skin flora of the hands of the
subjects were performed utilizing a glove juice protocol.
A standard surgical scrub wash was performed at least
once by each of the subjects each day for five (5) days.
A glove juice sampling procedure was performed at five
(5) minutes post wash, three (3) hours post wash and
six (6) hours post wash on days one (1), two (2) and five
(5) after the first wash of the day. Additional scrubs without glove juice sampling occurred on days two (2), three
(3) and four (4). Reference “OTC TopicalAntimicrobial
Products Tentative Final Monograph,” Federal
Register, Volume 43 (4): 1242-1243, 1978.
Independent Laboratory: Skyland Scientific
Services, Inc., Belgrade, MT.
Conclusion: The results show good immediate
and persistent antimicrobial effects of the product
on the skin micro flora of the hands, in which the
product was equivalent to or better than the
reference product.
32-128
64-128
16-32
16
4
16
4
8
8
8-16
8
16
Conclusion Chlorhexidine gluconate is very
effective against both Gram-positive and Gramnegative bacteria, yeast and fungal microorganisms.
Ingredients
Active Ingredient
Chlorhexidine Gluconate
(2% wt)
Also Contains:
Water
Isopropyl Alcohol
Surfactants
Ingredient Class
Antimicrobial Agent
Carrier
Carrier
Surfactant, Cleaning Agent
11
PROVON® Antimicrobial Skin Cleanser
with 2% CHG (continued)
Results: Percent Reduction of Skin Micro Flora on the Hands
12
PROVON® Medicated Lotion Soap with Chloroxylenol
(PCMX)
Efficacy Data — In Vitro (continued)
Microorganism
Dermatologist-tested.
Escherichia coli
(O157; H7)
Klebsiella pneumoniae
Listeria
monocytogenes
Pseudomonas
aeruginosa
Salmonella enteritidis
Salmonella typhimurium
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
(MRSA)
Streptococcus pyogenes
Stock No. 4201, 4202, 4203, 4206, 4208, 4520, 2102, 2202
Physical Characteristics
Color: Clear, Light Amber
Fragrance: Fresh, Clean Balsam
Viscosity: 3,000-7,000 cps
pH: 8.6-9.2
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: October 17, 1997
Results: Average score 0.09 (scale 0-4). Lower
scores indicate low potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
ATCC No. % Reduction
35150
11296
>99.999
>99.999
7644
>99.999
15442
13076
14028
*
11060
>99.999
>99.999
99.997
99.993
>99.999
33591
19615
99.014
>99.999
* Clinical isolate
Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria was
demonstrated.
Ingredients
Efficacy Data — In Vitro
Active Ingredient
Chloroxylenol 0.3%
Also Contains:
Water (Aqua)
Coconut Acid
Oleic Acid
Sodium Sulfate
Time-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15)- or thirty (30)- second exposure kill studies were performed
utilizing nineteen (19) challenge microorganisms.
The challenge inoculum was introduced to the test
product at time zero; a portion of the sample was
removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge
microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: October 13, 1998
Ethanolamine
Coco-Betaine
Aloe Barbadensis
Leaf Juice
Cocamide MEA
Hydrolyzed Vegetable
Protein
Hydroxypropyl
Methylcellulose
Propylene Glycol
Percent Reduction of Test Organisms After a
15-Second Exposure
Retinyl Palmitate
Microorganism
ATCC No. % Reduction
Acinetobacter baumannii
Campylobacter jejuni
Citrobacter freundii
Clostridium difficile
Clostridium perfringens
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Vancomycin resistant
Escherichia coli
19606
29428
8090
9689
13124
>99.999
>99.999
>98.554
>99.999
>99.999
Tetrasodium EDTA
Tocopheryl Acetate
51575
99.866
51559
11229
99.954
>99.999
Zea Mays (Corn) Oil
Fragrance (Parfum)
13
Ingredient Class
Antimicrobial Agent
Carrier
Cleansing Agent
Cleansing Agent
Viscosity Increasing
Agent
pH Adjuster
Cleansing Agent
Botanical Additive,
Skin Conditioning
Agent
Foam Booster,
Viscositiy Increasing
Agent
Skin Conditioning
Agent
Viscosity Increasing
Agent
Skin Conditioning
Agent, Humectant
Skin Conditioning
Agent
Chelating Agent
Skin Conditioning
Agent
Skin Conditioning
Agent
Fragrance
PROVON® Medicated Lotion Soap with Triclosan
Efficacy Data — In Vitro (continued)
Dermatologist-tested.
Microorganism
ATCC No.
% Reduction
Stock No. 4152, 4153, 2258, 2158
Salmonella typhimurium
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
Methicillin resistsant
Streptococcus pyogenes
14028
**
11060
>99.998
99.996
99.999
33591
19615
99.702
>99.999
Physical Characteristics
Color: Clear, Light Amber
Fragrance: Fresh, Clean Balsam
Viscosity: 2,700-15,300 cps
pH: 7.0-10.0
* 30-Second Exposure
** Clinical isolate
Conclusion: Very effective reduction of Gramnegative and Gram-positive bacteria by the
product was demonstrated.
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: June 19, 1998
Results: Average score 0.12 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Ingredients
Active Ingredient
Triclosan 0.3%
Also Contains:
Water (Aqua)
Coconut Acid
Sodium Sulfate
Oleic Acid
Ethanolamine
Coco-Betaine
Efficacy Data — In Vitro
Timed-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15) or thirty (30)second-exposure kill studies were performed
utilizing nineteen (19) challenge bacteria. The
challenge inoculum was introduced to the test
product at time zero; a portion of the sample was
removed and placed in neutralizing media at the appropriate time (15 seconds or 30 seconds). Standard plate
counting techniques were used to enumerate viable
challenge microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: October 13, 1998
Aloe Barbadensis
Leaf Juice
Cocamide MEA
Hydrolyzed Vegetable
Protein
Hydroxypropyl
Methylcellulose
Propylene Glycol
Retinyl Palmitate
Tetrasodium EDTA
Tocopheryl Acetate
Zea Mays (Corn) Oil
Fragrance (Parfum)
Methylchloroisothiazolinone
Methylisothiazolinone
Percent Reduction of Test Organisms After a
15-Second Exposure
Microorganism
ATCC No.
% Reduction
Acinetobacter baumannii
Campylobacter jejuni
Citrobacter freundii
Clostridium difficile
Clostridium perfringens
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Escherichia coli
(O157; H7)
Klebsiella pneumoniae
Listeria monocytogenes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella enteritidis
19606
29428
8090
9689
13124
>99.999
>99.999
>96.436*
>99.999
>99.999
51575
>99.988
51559
11229
>99.987
>99.999
35150
11296
7644
7002
15442
13076
>99.97
>99.999
>99.999
>95.640*
>99.999
>99.999
14
Ingredient Class
Antimicrobial Agent
Carrier
Cleansing Agent
Viscosity Increasing Agent
Cleansing Agent
pH Adjuster
Cleansing Agent, Skin
Conditioning Agent,
Foam Booster
Botanical Additive, Skin
Conditioning Agent
Foam Booster, Viscositiy
Increasing Agent
Skin Conditioning Agent
Viscosity Increasing Agent
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Fragrance
Preservative
Preservative
Ingredients
PROVON® Antimicrobial Lotion Soap
with 0.3% Chloroxylenol
Active Ingredient
Chloroxylenol 0.3%
Also Contains:
Water (Aqua)
Coconut Acid
Oleic Acid
Sodium Sulfate
Ethanolamine
Cocamide DEA
Dermatologist-tested.
Stock No. 4212, 4213, 4216, 4218, 4555, 2218, 2118
Physical Characteristics
Color: Clear Amber
Fragrance: Fresh Citrus
Viscosity: 2,700 - 15,300 cps
pH: 7.0-10.0
Sodium Laureth Sulfate
Sodium Lauryl Sulfate
Aloe Barbadensis
Leaf Juice
Propylene Glycol
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential
in humans.
Description of Test: 21-Day Cumulative Irritancy
Assay with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: October 17, 1997
Results: Average score 0.28 (scale 0 – 4);
no sensitization occured.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Soyamidopropyl Betaine
Tetrasodium EDTA
Tocopheryl Acetate
Hydroxypropyl
Methylcellulose
Sodium Chloride
Fragrance (Parfum)
Triclosan
Blue No. 1 (CI 42090)
Red No. 4 (CI 14700)
Red No. 33 (CI 17200)
Yellow No. 5 (CI 19140)
Efficacy Data — In Vitro
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Thirty (30)-second-exposure
kill studies were performed utilizing eighteen(18)
challenge bacterial strains. The challenge inoculum
was introduced to the test product at time zero; a
portion of the sample was removed and placed in
neutralizing media at the appropriate time (30 seconds). Standard plate counting techniques were
used to enumerate viable challenge microorganisms.
Independent Laboratory:
BioScience Laboratories, Inc., Bozeman, Montana
Date: April, 2001
Percent Reduction of Test Organisms
After a 30-Second Exposure
Microorganism
ATCC No. % Reduction
Citrobacter freundii
Enterococcus faecalis
Multi-drug resistant
Enterococcus faecium
Multi-drug resistant
8090
>99.999
51575
>99.991
51559
>99.992
33591
>97.576
>98.253
Staphylococcus aureus
Methicillin resistant
Staphylococcus epidermidis 12228
* 30-Second Exposure
Conclusion: Effective reduction of Gram-negative
and Gram-positive bacteria was demonstrated
15
Ingredient Class
Antimicrobial Agent
Carrier
Cleansing Agent
Cleansing Agent
Viscosity Increasing Agent
pH Adjuster
Surfactant, Foam Booster
Viscosity Increasing Agent
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Botanical Additive, Skin
Conditioning Agent
Skin Conditioning Agent,
Humectant
Cleansing Agent, Viscosity
Increasing Agent
Chelating Agent
Skin Conditioning Agent
Viscosity Increasing Agent
Viscosity Increasing Agent
Fragrance
Preservative
Colorant
Colorant
Colorant
Colorant
PROVON® Gentle Lotion Soap
PROVON® Mild Lotion Soap
Dermatologist-tested.
Dermatologist-tested.
Stock No. 4222, 4223, 4226, 4228, 2219, 2119
Stock No. 4008, 4019, 2208, 2108, 4508
Physical Characteristics
Physical Characteristics
Color: Light Yellow
Fragrance: Fresh, Clean
Viscosity: 2,700 - 15,300 cps
pH: 7.0-10.0
Irritancy Data and Allergy Test Results
Color: Blue Pearl
Fragrance: Fresh, Clean
Viscosity: 2,700-15,300 cps
pH: 7.0-10.0
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 18, 1997
Results: Average score 0.09 (scale 0-4). Lower
scores indicate lower potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Ingredients
Contents
Water
Cocamidopropyl Betaine
Coconut Acid
Oleic Acid
Sodium Sulfate
Ethanolamine
Aloe Barbadensis
Leaf Juice
Cocamide DEA
Hydrolyzed Vegetable
Protein
Polystyrene
Propylene glycol
Retinyl Palmitate
Tetrasodium EDTA
Tocopheryl Acetate
Zea Mays (Corn) Oil
Hydroxypropyl
Methylcellulose
Fragrance (Parfum)
Chloroxylenol
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy
Assay with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: May 7, 1993
Results: Average score 0.23 (scale 0-4). Lower
scores indicate lower potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Ingredients
Ingredient Class
Carrier
Cleansing Agent, Skin
Conditioning Agent
Cleansing Agent
Cleansing Agent
Viscosity Increasing Agent
pH Adjuster
Botanical Additive, Skin
Conditioning Agent
Surfactant, Foam Booster
Skin Conditioning Agent
Contents
Water (Aqua)
Coconut Acid
Oleic Acid
Sodium Sulfate
Ethanolamine
Cocamide DEA
Cocamidopropyl Betaine
Glycol Distearate
Lauramide DEA
Propylene Glycol
Sodium Laureth Sulfate
Tetrasodium EDTA
Fragrance (Parfum)
Chloroxylenol
Blue No. 1 (CI 42090)
Opacifier
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Viscosity Increasing Agent
Fragrance
Preservative
16
Ingredient Class
Carrier
Cleansing Agent
Cleansing Agent
Viscosity Increasing Agent
pH Adjuster
Surfactant, Foam Booster
Cleansing Agent
Pearlizing Agent, Emollient
Viscosity Increasing Agent
Skin Conditioning Agent,
Humectant
Surfactant, Cleansing Agent
Chelating Agent
Fragrance
Preservative
Colorant
PROVON® Enriched Lotion Cleanser
PROVON® Foaming Handwash with Moisturizers
Dermatologist-tested.
Dermatologist-tested.
Stock No.2213, 2113, 4013, 4017
Stock No. 5285, 5185, 5985
Physical Characteristics
Physical Characteristics
Color: Clear Pink
Fragrance: Cranberry
Form: Liquid
pH: 4.5-9.5
Color: Pink, pearled
Fragrance: Floral
Viscosity: 3,700- 20,000 cps
pH: 4.5- 9.5
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 9, 2001
Results: Average score 0.14 (scale 0-4). Lower
scores indicate lower potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the method
utilized for this evaluation. Fresh materials are applied
daily, 5 days per week, for 21 days to the same site
(patches were not moved or reapplied on the weekends).
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 5, 2002
Results: Average score = 0.16 (scale 0-4); No sensitization occurred.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Ingredients
Contents
Water (Aqua)
Sodium Laureth Sulfate
Cocamide DEA
Sodium Lauryl Sulfate
Ammonium Chloride
Disodium Laureth
Sulfosuccinate
Aloe Barbadensis
Leaf Juice
Cocamide MEA
Cocamidopropyl
PG-Dimonium
Chloride Phosphate
Glycerin
Glycol Distearate
Lactic Acid
Laureth-7
Retinyl Palmitate
Simmondsia Chinensis
(Jojoba) Seed Oil
Sodium C14-16
Olefin Sulfonate
Soyamidopropyl Betaine
Tocopheryl Acetate
Zea Mays (Corn) Oil
Sodium Chloride
Fragrance (Parfum)
DMDM Hydantoin
Red 33 (CI 17200)
Ingredient Class
Carrier
Surfactant, Cleansing Agent
Surfactant, Foam Booster,
Viscosity Increasing Agent
Surfactant, Cleansing Agent
Viscosity Increasing Agent
Surfactant, Cleansing Agent,
Foam Booster
Botanical Additive, Skin
Conditioning Agent
Foam Booster, Viscosity
Increasing Agent
Skin Conditioning Agent
Human Repeated Insult Patch Test
Objective: Determination of the dermal irritation
and sensitization potential of the product.
Description of Test: Human repeated insult
patch test.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, N.J.
Date: February 25, 2003
Results: No visible skin reactions were observed
during the induction or challenge phases of the study.
Conclusions: Test product demonstrated no
potential for eliciting either dermal irritation or
sensitization.
Skin Conditioning Agent,
Humectant
Pearlizing Agent, Emollient
pH Adjuster
Surfactant
Skin Conditioning Agent
Skin Conditioning Agent
Surfactant, Cleansing Agent
Cleansing Agent, Viscosity
Increasing Agent
Skin Conditioning Agent
Skin Conditioning Agent
Viscosity Increasing Agent
Fragrance
Preservative
Colorant
17
PROVON® Foaming Handwash with Moisturizers
(continued)
Ingredients
INCI Name*
Water (Aqua)
Ammonium Laureth Sulfate
Ammonium Lauryl Sulfate
Algae Extract
Aloe Barbadensis Leaf Juice
Ammonium Xylenesulfonate
Citric Acid
Cocamide MEA
Disodium Soyamphodiacetate
Glycerin
PEG-.80 Glyceryl Cocoate
Retinyl Palmitate
Simmondsia Chinensis (Jojoba)
Seed Oil
Tetrasodium EDTA
Trocopheryl Acetate
Zea Mays (Corn) Oil
Ammonium Sulfate
Fragrance (Parfum)
Quaternium-15
Red 40 (Cl 16035)
PROVON® Foaming Antimicrobial Handwash with
Moisturizers and 0.3% Chloroxylenol
Ingredient Class
Carrier
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Skin Conditioning Agent
Botanical Additive, Skin
Conditioning Agent
Surfactant, Cleansing Agent
pH Adjuster
Surfactant, Foam Booster,
Viscosity Increasing Agent
Cleansing Agent
Skin Conditioning Agent,
Humectant
Surfactant, Cleansing Agent
Skin Conditioning Agent
Skin Conditioning Agent
Dermatologist-tested.
Stock No. 5286, 5186, 5986
Physical Characteristics
Active Ingredient: 0.3% Chloroxylenol
Color: Clear Amber Orange
Fragrance: Floral
Form: Liquid
pH: 4.5-8.5
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: 21 Day Cummulative Irritancy
Assay with Challenge. Fresh materials are applied
daily, 6 days per week, for 21 days to the same site
(patches were not moved or reapplied on Sunday).
Independent Laboratory: RDTS, Inc., Irving, TX
Date: January 3, 2003
Results: Average score = 0.41 (scale 0-4); No sensitization occurred.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Thickener
Fragrance
Preservative
Colorant
*International Nomenclature Cosmetic Ingredient
Human Repeated Insult Patch Test
Objective: Determination of the dermal irritation
and sensitization potential of the product.
Description of Test: Human repeated insult
patch test.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, N.J.
Date: February 25, 2003
Results: No visible skin reactions were observed
during the induction or challenge phases of the study.
Conclusions: Test product demonstrated no
potential for eliciting either dermal irritation or
sensitization.
18
PROVON® Foaming Antimicrobial Handwash with
Moisturizers and 0.3% Chloroxylenol
(continued)
Ingredients
PROVON® Foaming Medicated Handwash with
Moisturizers and 0.5% Triclosan
INCI Name*
Ingredient Class
Dermatologist-tested.
Active:
Chloroxylenol
Also Contains:
Water (Aqua)
Alcohol Denat.
Ammonium Laureth Sulfate
Ammonium Lauryl Sulfate
Propylene Glycol
Algae Extract
Aloe Barbadensis Leaf Juice
Ammonium Xylenesulfonate
Cocamide MEA
Glycerin
Lactic Acid
Retinyl Palmitate
Simmondsia Chinensis (Jojoba)
Seed Oil
Tetrasodium EDTA
Trocopheryl Acetate
Zea Mays (Corn) Oil
Ammonium Sulfate
Fragrance (Parfum)
Methylchloroisothiazolinone
Methylisothiazolinone
Red 40 (Cl 16035)
Yellow 5 (Cl 19140)
Yellow 6 (Cl 15985)
Antiseptic Agent
Stock No. 5288, 5188, 5986, 5788
Carrier
Diluent, Solvent
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent
Botanical Additive, Skin
Conditioning Agent
Surfactant, Cleansing Agent
Surfactant, Foam Booster,
Viscosity Increasing Agent
Skin Conditioning Agent,
Humectant
pH Adjuster
Skin Conditioning Agent
Skin Conditioning Agent
Physical Characteristics
Active Ingredient: 0.5% Triclosan
Color: Clear Blue
Fragrance: Floral
Form: Liquid
pH: 4.5-8.0
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the method
utilized for this evaluation. Fresh materials are applied
daily, 5 days per week, for 21 days to the same site
(patches were not moved or reapplied on the weekends).
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, CA
Date: July 5, 2002
Results: Average score = 0.07 (scale 0-4); No sensitization occurred.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Thickener
Fragrance
Preservative
Preservative
Colorant
Colorant
Colorant
*International Nomenclature Cosmetic Ingredient
Human Repeated Insult Patch Test
Efficacy Data — In Vitro
Objective: Determination of the dermal irritation
and sensitization potential of the product.
Description of Test: Human repeated insult
patch test.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, N.J.
Date: February 25, 2003
Results: No visible skin reactions were observed
during the induction or challenge phases of the study.
Conclusions: Test product demonstrated no
potential for eliciting either dermal irritation or
sensitization.
Objective: Evaluate the antimicrobial effectiveness of
the product in vitro.
Description of Test: Fifteen(15) or thirty (30)-secondexposure kill evaluations were performed
utilizing ten(10) challenge bacterial strains.
The challenge inoculum was introduced to the test product
at time zero; a portion of the sample was removed and
placed in neutralizing media at the
appropriate time (15 or 30 seconds). Standard plate
counting techniques were used to enumerate viable challenge microorganisms.
Independent Laboratory:
BioScience Laboratories, Inc., Bozeman, Montana
Dates: February 14, 2003
Percent Reduction of Test Organisms
After a 15-Second Exposure
Challenge Microbe
ATCC No. % Reduction
Acinetobacter baumannii
Bacillus megaterium
Clostridium difficile
Corynebacterium
diphtheriae
Enterococcus faecalis
(VRE)
Enterococcus Faecium
(VRE)
Listeria monocytogenes
Proteus vulgaris
Streptococcus pneumonie
Streptococcus pyogenes
19606
14581
9689
11913
>99.999
>99.999
>99.999
>99.997
51575
>98.938*
51599
>99.796
15313
13315
33400
19615
>98.757*
>99.935
>99.996
>99.999
* 30 Second Exposure
19
PROVON® Foaming Medicated Handwash with
Moisturizers and 0.5% Triclosan
(continued)
Ingredients
INCI Name*
Efficacy Data — In Vitro
Ingredient Class
Timed-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15) or thirty (30)second-exposure kill evaluations were performed
utilizing twenty-seven (27) challenge bacterial strains.
The challenge inoculum was introduced to the test
product at time zero; a portion of the sample was
removed and placed in neutralizing media at the appropriate time (15 seconds or 30 seconds). Standard plate
counting techniques were used to enumerate viable
challenge microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: February 14, 2003
Active:
Triclosan
Also Contains:
Water (Aqua)
Lauramidopropylamine Oxide
Propylene Glycol
Didecyldimonium Chloride
Alcohol Denat.
Aloe Barbadensis Leaf Juice
Glycerin
Lactic Acid
Retinyl Palmitate
Simmondsia Chinensis (Jojoba)
Seed Oil
Tetrasodium EDTA
Trocopheryl Acetate
Zea Mays (Corn) Oil
Fragrance (Parfum)
Chloroxylenol
Diazolidinyl Urea
Methylparaben
Propylparaben
Blue 1 (Cl 42090)
Antiseptic Agent
Carrier
Surfactant, Cleansing Agent
Skin Conditioning Agent,
Humectant
Conditioning Agent
Diluent, Solvent
Botanical Additive, Skin
Conditioning Agent
Skin Conditioning Agent,
Humectant
pH Adjuster
Skin Conditioning Agent
Skin Conditioning Agent
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Fragrance
Preservative
Preservative
Preservative
Preservative
Colorant
Percent Reduction of Test Organisms After a
15-Second Exposure
*International Nomenclature Cosmetic Ingredient
Challenge Microbe
ATCC No.
% Reduction
Acinetobacter baumannii
Bacillus megaterium
Campylobacter jejuni
Citrobacter freundii
Clostridium difficile
Corynebacterium diphtheriae
Enterobacter aerogenes
Enterococcus faecalis
(VRE)
Enterococcus faecium
(VRE)
Escherichia coli
Escherichia coli
(O157; H7)
Klebsiella pneumoniae
Subsp. Ozaenae
Klebsiella pneumoniae
Subsp. Pneumoniae
Lactobacillus plantarum
Listeria monocytogenes
Proteus vulgaris
Pseudomonas aeruginosa
Salmonella choleraesuis
Serotype Enteritidis
Salmonella choleraesuis
Serotype Typhimurium
Shigella dysenteriae
Shigella sonnei
Staphylococcus aureus
(MRSA)
Staphylococcus aureus
(MRSA)
Staphylococcus aureus
(VISA)
Staphylococcus epidermidis
Staphylococcus pneumonia
Staphylococcus pyogenes
19606
14581
29428
8090
9689
11913
13048
51575
>99.999
>99.999
>99.982
>99.999
>99.999
>99.997
>99.858
>99.999
51559
>99.999
11229
35150
>99.999
>99.999
11296
>99.999
13883
>99.999
14917
15313
13315
15442
13076
>99.999
>99.999
>99.999
>99.999
>99.999
14028
>99.999
13313
11060
33591
>99.999
>99.999
>99.999
080599MRSA*
>99.999
042800VISA*
>93.781**
12228
33400
19615
>99.999
>99.996
>99.999
*Clinical Isolate **30 Second Exposure
20
PROVON® Foaming Medicated Handwash with
Moisturizers and 0.5% Triclosan
(continued)
Efficacy Data — In Vivo
Healthcare Personnel Handwash Data
Objective: This study evaluated the antimicrobial
effectiveness of three (3) test products and on (1) reference product using a Healthcare Personnel Handwash
Procedure, as per methodology specified by the Food
and Drug Administration (FR 43:4, 06 Jan 78, pp.
1210-1248).
Description of Test: The antimicrobial effectiveness
and irritation potential of three (3) test products and
one (1) reference product for use as Health Care
Personnel Handwashes were determined using ten
(10) consecutive hand contamination/product application procedures, followed by an additional fifteen (15)
applications of product. Serratia marcescens (ATCC
#14756) was the marker organism used for hand contaminations. Seventy-two (72) human subjects were
utilized for the test. Microbial samples were taken at
baseline and after product applications one (1), three
(3), seven (7), and ten (10), followed by fifteen (15) additional washes with irritation evaluations performed after
wash fifteen (15), twenty (20), and twenty-five (25). All
sampling of the hands was performed using the Glove
Juice Sampling Procedure. The testing methods were
based on the Food and Drug Administration 1978
Tentative Final Monograph (TFM) (FR 45:1210, 6 Jan
78, pp. 1210-1248).
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, MT
Date: January 31, 2003
Results:
Wash
Antibacterial
Reference
Number
Reduction
Reduction
Log10
Log10
1
3
7
10
2.10
2.32
2.77
3.00
2.60
3.48
3.94
4.08
Conclusion: Product meets the protocol for a
Healthcare Personnel Handwash.
21
Bathing & Moisturizing
PROVON® Antibacterial Body Wash
Efficacy Data — In Vitro (continued)
Dermatologist-tested.
Stock No. 4026, 4029
Microorganism
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus aureus
Methicillin resistant
Physical Characteristics
Color: Dye-free, Colorless
Fragrance: Floral Musk
pH: 4.5-7.0
Irritancy Data and Allergy Test Results
Active Ingredient
Triclosan 0.15%
Also Contains:
Water (Aqua)
Sodium Lactate
Coco-Betaine
Disodium EDTA
Lactic Acid
Lauramine Oxide
PEG-4
Fragrance (Parfum)
Iodopropynyl
Butylcarbamate
Percent Reduction of Test Organisms After a 15Second Exposure
8090
9869
>99.999
>99.999*
51575
19434
>99.999
>99.999*
51559
>99.999
>99.999
Ingredients
Timed-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15)- or thirty (30)second-exposure kill studies were performed utilizing thirteen (13) challenge bacteria. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was
removed and placed in neutralizing media at the
appropriate time (15 or 30 seconds). Standard
plate counting techniques were used to enumerate viable challenge microorganisms.
Independent Laboratory: BioScience
Laboratories, Inc., Bozeman, Montana.
Date: July 19, 1994, October 20, 1994,
September 11,1995, and December 2, 1997.
% Reduction
>99.999
33591
Conclusion: Very effective reduction of Gramnegative and Gram-positive bacteria by the
product was demonstrated.
Efficacy Data — In Vitro
ATCC No.
19606
% Reduction
>99.999*
>99.999
>99.999*
>99.999
>99.999*
>99.999*
* 30-Second Exposure
Objective: Evaluation of irritation potential
in humans.
Description of Test: 21-Day Human Irritancy
Assay with Delayed Challenge.
Independent Laboratory: Dermatologic
Research Laboratory, San Francisco, California.
Date: August 17, 1999
Results: Average score 0.00 (scale 0-4). Lower
scores indicate low potential for skin
irritation
and allergic contact dermatitis.
Conclusion: Product has a low potential for
skin irritation and allergic contact dermatitis.
Microorganism
Acinetobacter
baumannii
Citrobacter freundii
Clostridium difficile
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Enterococcus faecium
Vancomycin resistant
ATCC No.
8739
11296
7002
15442
14756
6538
22
Ingredient Class
Antimicrobial Agent
Carrier
Skin Conditioning Agent,
Humectant
Surfactant, Cleansing Agent
Chelating Agent
pH Adjuster
Surfactant, Cleansing Agent
Humectant
Fragrance
Preservative
PROVON® Moisturizing Bathing Cloths
Dermatologist-tested.
Stock No. 4475
Physical Characteristics
Appearance: Soft white cloth
Fragrance: Light fresh scent
Form: Towel
pH: 5.0-6.0
Irritancy Data and Allergy Test Results
Objective: Determination of sensitizing properties of one
(1) product by Draize repeated insult patch test in human
volunteers.
Description of Test: Patch with test article was
applied to its designated contact site on 50 panelists
and remained in place for 24 hours at which time it
was removed and examined for dermal response.
This procedure was repeated on Mondays,
Wednesdays, and Fridays until a series of nine applications were made. A challenge phase occurred 2
weeks after the ninth application.
Independent Laboratory: The Institute for Skin
Research, Tel Aviv Israel.
Date: November 27, 1996
Results: No reaction was observed in any of the volunteers.
Conclusion: Low potential for irritation or sensitization with this product.
Ingredients
Contents
Water
Polysorbate 20
Propylene Glycol
Ingredient Class
Carrier
Surfactant-emulsifying agent
Skin conditioning agenthumectant
Aloe Barbadensis Leaf Juice
Skin conditioning agent
Citric Acid
pH adjuster
Disodium Cocoamphodiacetate
Surfactant-cleansing agent
Sodium Citrate
pH adjuster
Sodium Laureth Sulfate
Surfactant-cleansing agent
Tetrasodium EDTA
Chelating agent
Fragrance (Parfum)
Fragrance
2-Bromo-2-Nitropropane-1,3-Diol Preservative
Benzalkonium Chloride
Cosmetic biocide
Benzyl Alcohol
Preservative
Methylchloroisothiazolinone
Preservative
Methylisothiazolinone
Preservative
Methylparaben
Preservative
*International Nomenclature Cosmetic Ingredient
23
PROVON® Conditioning Shampoo & Body Wash
PROVON® Tearless Shampoo & Body Wash
Dermatologist-tested.
Dermatologist-tested.
Stock No. 2127, 2227, 4127, 4446, 4037
Stock No. 4032, 4034, 4402, 4403, 4405, 4406, 4408, 2234,
2134
Physical Characteristics
Physical Characteristics
Color: Peach colored pearled viscous liquid
Fragrance: Fruity
Form: Liquid
pH: 5.0-8.0
Color: Clear, Blue
Fragrance: Floral Fruity
Viscosity: 4,000- 10,000 cps
pH: 5.5- 6.5
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the method
utilized for this evaluation. Fresh materials are applied
daily, 5 days per week, for 21 days to the same site
(patches were not moved or reapplied on the weekends).
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 5, 2002
Results: Average score = 0.18 (scale 0-4); No sensitization occured.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Objective: Evaluation of irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 5, 2000.
Results: Average score 0.00 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Tearless Test Results
Description of Test: Comparative human eye irritation / Sting potential study.
Independent Laboratory: Essex Testing Clinic,
Inc.
Date: May 19, 2000.
Conclusion: Tearless shampoo is considered to be
“tear-free”
Ingredients
INCI Name*
Water (Aqua)
Cocamide DEA
Sodium Laureth Sulfate
Sodium Lauryl Sulfate
Disodium Laureth Sulfosuccinate
Cocamidopropyl Betaine
Ammonium Chloride
Soyamidopropyl Betaine
Ingredient Class
Carrier
Surfactant, Foam Booster
Surfactant, Foam Booster
Surfactant, Cleansing Agent
Surfactant
Surfactant, Foam Booster
Viscosity Increasing Agent
Cleansing Agent, Skin
Conditioning Agent, Foam
Booster
Glycol Distearate
Emollient Pearlizing Agent
Lactic Acid
pH Adjuster
DMDM Hydantoin
Preservative
Fragrance (Parfum)
Fragrance
Lauramide DEA
Surfactant, Foam Booster,
Viscosity Increasing Agent
Glycerin
Skin Conditioning Agent,
Humectant
Tetrasodium EDTA
Chelating Agent
Polyquaternium-10
Conditioning Agent
Sodium Chloride
Viscosity Increasing Agent
Linoleamidopropyl PG-Dimonium Hair Conditioning Agent
Chloride Phosphate Dimethicone
Cocamidopropyl PG-Dimonium Conditioning Agent
Chloride Phosphate
Aloe Barbadensis Leaf Juice
Botanical Additive, Skin
Conditioning Agent
Simmondsia Chinensis (Jojoba) Skin Conditioning Agent
Seed Oil
Tocopheryl Acetate
Skin Conditioning Agent
Red 40 (CI 16035)
Colorant
Retinyl Palmitate
Skin Conditioning Agent
Yellow 5 (CI 19140)
Colorant
Zea Mays (Corn) Oil
Skin Conditioning Agent
Ingredients
Contents
Water (Aqua)
PEG-80 Sorbitan Laurate
Cocamidopropyl Betaine
Sodium Trideceth Sulfate
PEG-150 Distearate
Sodium Lauroamphoacetate
Aloe Barbadensis
Leaf Juice
Citric Acid
Glycerin
Polyquaternium-10
Retinyl Palmitate
Sodium Laureth13 Carboxylate
Tetrasodium EDTA
Tocopheryl Acetate
Zea Mays (Corn) Oil
Fragrance (Parfum)
Quaternium-15
Blue No. 1 (CI 42090)
*International Nomenclature Cosmetic Ingredient
24
Ingredient Class
Carrier
Surfactant, Cleansing Agent
Surfactant, Foam Booster,
Viscosity Increasing Agent
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Hair Conditioning Agent,
Surfactant, Cleansing
Agent, Foam Booster
Botanical Additive, Skin
Conditioning Agent
pH Adjuster
Humectant
Antistatic Agent
Skin Conditioning Agent
Surfactant, Cleansing Agent
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Fragrance
Preservative
Colorant
PROVON® Enriched Shampoo for Body & Hair
PROVON® Foaming Hair & Body Wash with
Moisturizers
Dermatologist-tested.
Dermatologist-tested.
Stock No. 4012, 4014, 4015, 4016, 4018, 4033, 4035, 2133, 2233
Stock No. 5287, 5187, 5987, 5787
Physical Characteristics
Physical Characteristics
Color: Clear Yellow
Fragrance: Herbal
Viscosity: 5,700-18,300 cps
pH: 4.5-8.0
Color: Clear Green
Fragrance: Cucumber Melon
Form: Liquid
pH: 4.5-9.5
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 10, 1992
Results: Average score 0.28 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Objective: Evaluation of skin irritation potential in
humans.
Description of Test: Phillips et al (Toxic and Applied
Pharmacology 21: 369-382) summarizes the method
utilized for this evaluation. Fresh materials are applied
daily, 5 days per week, for 21 days to the same site
(patches were not moved or reapplied on the weekends).
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: July 5, 2002
Results: Average score = 0.18 (scale 0-4); No sensitization occured.
Conclusion: The product has a low potential for skin
irritation and allergic contact dermatitis.
Ingredients
Contents
Water (Aqua)
Sodium Laureth Sulfate
Cocamide DEA
Sodium Lauryl Sulfate
Soyamidopropyl
Betaine
Aloe Barbadensis
Leaf Juice
Ammonium Chloride
Citric Acid
Sodium Chloride
Tocopheryl Acetate
Fragrance (Parfum)
DMDM Hydantoin
Red No. 40 (CI 16035)
Yellow No. 5 (CI 19140)
Yellow No. 6 (CI 15985)
Ingredient Class
Carrier
Surfactant, Cleansing
Agent
Surfactant, Foam
Booster
Surfactant, Cleansing
Agent
Cleansing Agent,
Skin Conditioning
Agent, Foam
Booster
Botanical Additive,
Skin Conditioning
Agent
Viscosity Increasing
Agent
pH Adjuster, Chelating
Agent
Viscosity Increasing
Agent
Skin Conditioning
Agent
Fragrance
Preservative
Colorant
Colorant
Colorant
Human Repeated Insult Patch Test
Objective: Determination of the dermal irritation and
sensitization potential of the product.
Description of Test: Human repeated insult patch test.
Independent Laboratory: Clinical Research
Laboratories, Inc., Piscataway, New Jersey.
Date: February 25, 2003
Results: No visible skin reactions were observed during
the induction or challenge phases of the study.
Conclusion: Test product demonstrated no potential for
eliciting either dermal irritation or sensitization.
25
PROVON® Foaming Hair & Body Wash with
Moisturizers (continued)
PROVON® Moisturizing Hand & Body Lotion
Ingredients
INCI Name*
Water (Aqua)
Ammonium Laureth Sulfate
Ammonium Lauryl Sulfate
Cocamide MEA
Aloe Barbadensis Leaf Juice
Ammonium Xylenesulfonate
Citric Acid
Disodium Soyamphodiacetate
Glycerin
PEG-80 Glyceryl Cocoate
Quaternium-52
Retinyl Palmitate
Simmondsia Chinensis (Jojoba)
Seed Oil
Tetrasodium EDTA
Tocopheryl Acetate
Wheat Amino Acids
Zea Mays (Corn) Oil
Ammonium Sulfate
Fragrance (Parfum)
Quaternium-15
Blue 1 (Cl 42090)
Yellow 10 (Cl 47005)
Dermatologist-tested. CHG compatible. Latex compatible.
Ingredient Class
Carrier
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Surfactant, Foam Booster
Viscosity Increasing Agent
Botanical Additive, Skin
Conditioning Agent
Surfactant, Cleansing Agent
pH Adjuster
Cleansing Agent
Skin Conditioning Agent,
Humectant
Surfectant, Cleansing Agent
Cleansing Agent, Skin
Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
Stock No. 4231, 4232, 4233, 4236, 4238, 2533
Physical Characteristics
Color: Creamy Opaque
Fragrance: No Cosmetic Fragrance
Viscosity: 10,000-22,000 cps
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential in
humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: August 17, 1999
Results: Average score 0.23 (scale 0-4). Lower
scores indicate low potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
Thickener
Fragrance
Preservative
Colorant
Colorant
Ingredients
*International Nomenclature Cosmetic Ingredient
Contents
Water (Aqua)
Petrolatum
Distearyldimonium Chloride
Glycerin
Isopropyl Myristate
Cetyl Alcohol
Dimethicone
Fragrance (Parfum)
Butylparaben
Isobutylparaben
Isopropylparaben
Quaternium-15
26
Ingredient Class
Carrier
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent,
Emollient
Skin Conditioning Agent,
Emollient
Skin Conditioning Agent
Fragrance
Preservative
Preservative
Preservative
Preservative
Perineal Skin Care
PROVON® Skin Moisturizer with Aloe & Vitamins
PROVON® Perineal Wash
Dermatologist-tested.
Dermatologist-tested.
Stock No. 4251, 4252
Stock No. 4422, 4424, 4426
Physical Characteristics
Physical Characteristics
Color: Green
Fragrance: Citrus Oriental
pH: 5.0-8.5
Color: Creamy Opaque
Fragrance: Floral
Viscosity: 5,000-33,000 cps
pH: 4.5-8.5
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: June 11, 1999
Results: Average score 0.01 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 24, 1992
Results: Average score 0.03 (scale 0-4). Lower
scores indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis.
Ingredients
Ingredients
Contents
Water (Aqua)
Glycerin
Stearic Acid
Cetyl Alcohol
Aloe Barbadensis
Leaf Juice
Dimethicone
Mineral Oil
(Paraffinum Liquidum)
Retinyl Palmitate
Tocopheryl Acetate
Zea Mays (Corn) Oil
Triethanolamine
Fragrance (Parfum)
Phenoxyethanol
DMDM Hydantoin
Iodopropynyl
Butylcarbamate
Contents
Water (Aqua)
Aloe Barbadensis Leaf Juice
Ingredient Class
Carrier
Skin Conditioning Agent,
Humectant
Viscosity Increasing,
Skin Conditioning Agent
Skin Conditioning Agent,
Emollient
Botanical Additive, Skin
Conditioning Agent
Skin Conditioning Agent
Emollient, Skin Conditioning
Agent
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
pH Adjuster
Fragrance
Preservative
Preservative
Preservative
Citric Acid
Cocamidopropyl
PG-Dimonium Chloride
Phosphate
Coco-Betaine
Lauramine Oxide
Retinyl Palmitate
Tetrasodium EDTA
Tocopheryl Acetate
Zea Mays (Corn) Oil
Fragrance (Parfum)
DMDM Hydantoin
Iodopropynyl
Butylcarbamate
Blue 1 (CI 42090)
Yellow 5 (CI 19140)
27
Ingredient Class
Carrier
Botanical Additive, Skin
Conditioning Agent
pH Adjuster
Skin Conditioning Agent
Surfactant, Cleansing Agent
Surfactant, Cleansing Agent
Skin Conditioning Agent
Chelating Agent
Skin Conditioning Agent
Skin Conditioning Agent
Fragrance
Preservative
Preservative
Colorant
Colorant
Efficacy Data — In Vitro (continued)
PROVON® Antibacterial Perineal Wash
Dermatologist-tested, dye-free. U.S. Pat. 5,635,462.
Microorganism
Stock No. 4432, 4436, 4434
Staphylococcus
aureus
Staphylococcus aureus
Methicillin resistant
Physical Characteristics
Color: Colorless (dye-free)
Fragrance: Fresh and Light
Viscosity: 100 cps
pH: 5.8-6.2
>99.999
33591
>99.999
Ingredients
Active Ingredient
Triclosan 0.15%
Also Contains:
Water (Aqua)
Sodium Lactate
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy
Assay with Delayed Challenge.
Independent Laboratory: Dermatologic
Research Laboratory, San Francisco, California.
Date: August 17, 1999
Results: Average score 0.00 (scale 0-4). Lower scores
indicate low potential for skin irritation and
allergic contact dermatitis.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Coco-Betaine
Disodium EDTA
Lactic Acid
Lauramine Oxide
PEG-4
Humectant
Fragrance (Parfum)
Iodopropynyl
Butylcarbamate
Efficacy Data — In Vitro
Timed-Exposure Kill Tests
Objective: Evaluation of the antimicrobial
effectiveness of the product in vitro.
Description of Test: Fifteen (15) or thirty (30)-secondexposure kill studies were performed utilizing thirteen (13)
challenge bacteria. The challenge inoculum was introduced to the test product at time zero; a portion
of the sample was removed and placed in neutralizing
media at the appropriate time. Standard plate counting
techniques were used to enumerate viable challenge
microorganisms.
Independent Laboratory: BioScience Laboratories,
Inc., Bozeman, Montana.
Dates: July 19, 1994; October 20, 1994;
September 11, 1995; December 2, 1997.
Percent Reduction of Test Organisms
After a 30-Second Exposure
Acinetobacter
baumannii
Citrobacter freundii
Clostridium difficile
Enterococcus faecalis
Vancomycin resistant
Enterococcus faecium
Enterococcus faecium
Vancomycin resistant
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas
aeruginosa
Serratia marcescens
6538
Conclusion: Very effective reduction of Gramnegative and Gram-positive bacteria by the
product was demonstrated.
Irritancy Data and Allergy Test Results
Microorganism
ATCC No. % Reduction
ATCC No. % Reduction
19606
8090
9869
>99.999
>99.999
>99.999
51575
19434
>99.999
>99.999
51559
8739
11296
7002
>99.999
>99.999
>99.999
>99.999
15442
14756
>99.999
>99.999
28
Ingredient Class
Antimicrobial Agent
Carrier
Skin Conditioning Agent,
Humectant
Surfactant, Cleansing Agent
Chelating Agent
pH Adjuster
Surfactant, Cleansing Agent
Fragrance
Preservative
PROVON® Moisturizing Perineal Skin Protectant with
Petrolatum
PROVON® Personal Wash Cloths
Dermatologist-tested.
Dermatologist-tested.
Stock No. 4471, 4472, 4470
Stock No. 4441
Physical Characteristics
Physical Characteristics
Appearance: Soft white cloth
Fragrance: Light fresh scent
Form: Towel
pH: 5.0-6.0
Color: Dye-free, Creamy White
Fragrance: Fresh and Light
Viscosity: Nongreasy, Semisolid
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Determine whether any of a series of test
materials produces primary irritation under a single Patch
test on selected persons.
Description of Test: A test is conducted using a
specific solution to identify individuals with sensitive
skin. A minimum of 10 participants with sensitive skin
are required. Following the pretest, the test product is
applied for 48 hours to all subjects and evaluated at 1
hour, 24 hours and after removal of the patch. The
site is ranked on a 0-4 scale.
Independent Laboratory: The Institute for Skin
Research, Tel Aviv Israel.
Date: February 18, 2001
Results: There were 50 panelist with 16 classified as
having sensitive skin. No reaction was observed in
any of the volunteers in the irritation patch test.
Conclusion: The product is not irritating on sensitive
skin.
Objective: Evaluation of irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 24, 1992
Results: Average score 0 (scale 0-4). Lower scores
indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Lower potential for skin irritation and
allergic contact dermatitis as indicated by a score
of zero (0).
Ingredients
Active Ingredient
Petrolatum, 60%
Also Contains:
Aluminum Starch
Octenylsuccinate
Fragrance (Parfum)
Methyldibromo
Glutaronitrile
Phenoxyethanol
Ingredients
Contents
Water
Mineral Oil
Trilaureth-4-phophate
Cocamidopropyl Betaine
Iodopropynyl Butylcarbomate
Fragrance (Parfum)
Disodium EDTA
Allantoin
2-Bromo-2-nitropropane-1,3-diol
Panthenol
Chamomilla Recutita (Matricaria)
Extract
Sodium Citrate
Citric Acid
Dimethicone
Ingredient Class
Carrier
Skin Conditioning Agent
Surfactant
Skin Conditioning Agent
Preservative
Fragrance
Chelating Agent
Skin Conditioning Agent
Preservative
Conditioning Agent
Cosmetic Biocide
pH Adjuster
pH Adjuster
Skin Conditioning Agent
*International Nomenclature Cosmetic Ingredient
29
Ingredient Class
Skin Protectant
Texture Enhancer
Fragrance
Preservative
Preservative
PROVON® Perineal Cream
PROVON® Perineal Ointment with Petrolatum
Dermatologist-tested.
Dermatologist-tested.
Stock No. 4421
Stock No. 4428, 4429
Physical Characteristics
Physical Characteristics
Color: White Opaque
Fragrance: Floral
Viscosity: 5,000-33,000 cps minimum (cream)
Color: Blue Opaque
Fragrance: Oriental Citrus
Viscosity: Semisolid
Irritancy Data and Allergy Test Results
Irritancy Data and Allergy Test Results
Objective: Evaluation of irritation potential
in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: November 24, 1992
Results: Average score 0.10 (scale 0-4). Lower scores
indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Product has a low potential for skin
irritation and allergic contact dermatitis.
Objective: Evaluation of irritation potential in humans.
Description of Test: 21-Day Human Irritancy Assay
with Delayed Challenge.
Independent Laboratory: Dermatologic Research
Laboratory, San Francisco, California.
Date: August 17, 1999
Results: Average score 0 (scale 0-4). Lower scores
indicate low potential for skin irritation and allergic contact dermatitis.
Conclusion: Lower potential for skin irritation and
allergic contact dermatitis as indicated by a score of
zero (0).
Ingredients
Contents:
Water (Aqua)
Lanolin Oil
Glycerin
Cetyl Alcohol
Sodium Lauryl Sulfate
Beeswax (Cera Alba)
Allantoin
Aloe Barbadensis
Leaf Juice
Antioxidant
Conditioning Agent
Agent
Skin Conditioning Agent
Conditioning Agent
Conditioning Agent
Viscosity Increasing
Crosspolymer
Xanthan Gum
Agent
(Parfum)
Methylparaben
Propylparaben
Quaternium-15
Ingredients
Carrier
Skin Conditioning Agent,
Emollient
Skin Conditioning Agent,
Humectant
Skin Conditioning Agent,
Emollient
Surfactant, Emulsifier
Skin Conditioning Agent
Skin Conditioning Agent
Botanical Additive, Skin
Conditioning AgentBHT
Cholecalciferol
Skin
Panthenol Skin Conditioning
Retinyl Palmitate
Tocopheryl Acetate Skin
Zea Mays (Corn) Oil Skin
Acrylates/C10-30 Alkyl
Acrylate
Agent
Viscosity Increasing
Fragrance
Fragrance
Preservative
Preservative
Preservative
30
Active Ingredient
Petrolatum 99%
Inactive Ingredients:
Cholecalciferol
Lanolin
Retinyl Palmitate
Sodium Caseinate
Sorbitan Oleate
Tocopheryl Acetate
Zea Mays (Corn) Oil
Fragrance (Parfum)
Methyldibromo Glutaronitrile
Phenoxyethanol
Green 6 (CI 61565)
Ingredient Class
Skin Protectant
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
Skin Conditioning Agent
Surfactant, Emulsifying
Agent
Skin Conditioning Agent
Skin Conditioning Agent
Fragrance
Preservative
Preservative
Colorant
NOTES
31
NOTES
32
GLOSSARY OF TERMS
21-Day Human Irritancy Assay
with Delayed Challenge
A standard patch test method used to determine the irritancy and allergic (sensitization)
potential of a product applied to human skin.
Antibacterial
A substance that kills or inhibits the growth of bacteria.
Antimicrobial
A substance that kills or inhibits the growth of microorganisms.
Antiseptic
A substance that kills or inhibits the growth of disease-causing microorganisms.
ASTM
American Society for Testing and Materials
CHG Compatible
Products that have no inhibitory effect on the antimicrobial efficacy of products containing
CHG (see Chlorhexidine Gluconate (CHG)).
Chlorhexidine Gluconate (CHG)
A topical antimicrobial active ingredient.
Chloroxylenol
A topical antimicrobial active ingredient. Also known as PCMX.
Glove Juice Technique
An in vivo technique used to enumerate microbial flora on the hands. (see In vivo).
Gram-negative bacteria
A primary characteristic of bacteria that possesses a thin cell wall. Used as a general classification of bacteria.
Gram-positive bacteria
A primary characteristic of bacteria that possesses a thick cell wall. Used as a general classification of bacteria.
Healthcare Personnel
Handwash Test
A standard test method developed by the American Society for Testing and Materials (ASTM)
that is designed to determine the ability of an antimicrobial handwashing agent to give
reduction of transient microbial flora when used in a handwashing procedure (see In vivo).
Human Repeated Insult
Patch Test
A repeated insult patch test procedure for determining irritancy and allergic potential of a
product on the skin using human subjects.
In vitro
Latin term that means “in glass.” This term is used in reference to scientific tests that are
conducted in glass beakers, Petri dishes, etc.
In vivo
Latin term that means “in a living body.” This term is used in reference to scientific tests that
are conducted on humans.
Latex Compatible
Products that will not adversely affect the physical properties of latex gloves.
Log Kill
A measurement of the reduction in bacteria, virus, or fungi challenge numbers as measured
in log base 10.
Petrolatum
Also known as petroleum jelly. A grade of hydrocarbon waxes known to be a skin moisturizer. At higher concentrations, this chemical can be used as a skin protectant.
pH Level
A measure of the acidity or alkalinity of a solution. Equal to 7 for neutral solutions and
increasing with increased alkalinity, decreasing with increased acidity.
Retinyl Palmitate
Vitamin A.
Surgical Scrub Test
An in vivo procedure which measures the antimicrobial efficacy of a surgical scrub product
(see In vivo).
Tocopheryl Acetate
Vitamin E.
Triclosan
A topical antimicrobial active ingredient.
PURELL and PROVON .
®
®
Cost-effective solutions for preventing the
spread of infection and maintaining healthy skin.
PROVEN SKIN CARE REGIMENS
• PURELL® Instant Hand Sanitizer -- America’s number one brand,
should be used frequently to disinfect hands. Kills 99.99% of most
common germs that may cause disease in as little as 15 seconds.
• PROVON® hand hygiene products -- Effective ways of preventing the
spread of germs in healthcare settings.
• PROVON bathing & moisturizing products -- Bathing products to help
clean, and control odors. Moisturizing products help restore
and protect dry, irritated skin.
• PROVON perineal care products -- Help maintain healthy skin and
leaves skin smelling clean and fresh.
RELIABLE DISPENSING SYSTEMS
• Removes the obstacles that can affect Healthcare Worker’s compliance.
• A variety of practical, reliable and alternative dispensing options.
• Easy-to-clean dispensers engineered for durability.
• Refilling systems help staff service dispensers quickly
and efficiently.
• Guaranteed for life.
EFFECTIVE TRAINING
• Comprehensive skin care inservice programs for healthcare personnel.
• Continuing education to support ongoing training needs.
• Self study (1.5 CE) course for nurses on hand hygiene.
GOJO Industries, Inc.
Professional Markets Group
P.O. Box 991, Akron, OH 44309-0991
800-321-9647 • 800-FAX-GOJO
www.GOJO.com
©2004. GOJO Industries, Inc. All rights reserved.
LIT-PRV-TIB (12/03)