Download 2012 Fluoride Therapy Guide

YOUR PARTNER IN ORAL HEALTH
2012 Fluoride Therapy Guide
AT-HOME
FLUORIDE
Neutral Sodium Fluorides
Colgate® PreviDent® 5000
BOOSTER
(Rx Only)
Colgate® PreviDent® 5000
SENSITIVE
(Rx Only)
Prescription Strength
Toothpaste
Prescription Strength
Toothpaste for Sensitive Teeth
Active
Ingredient
1.1% sodium fluoride (5000 ppm F-)
• 1.1% sodium fluoride (5000 ppm F-)
• 5% potassium nitrate
Patient
Condition
• Medium to high caries risk
• Orthodontic decalcification
• Dentin hypersensitivity
• Medium to high caries risk
• Root exposure
Mode of Action
• Fluoride inhibits demineralization of dental enamel, stimulates
remineralization and reduces acid production in plaque
• Liquid gel formula enables faster fluoride dispersion than pasteform Rx toothpaste1
• Fluoride inhibits demineralization of dental enamel, stimulates
remineralization and reduces acid production in plaque
• Potassium nitrate desensitizes the pulpal nerve endings to provide
clinically proven sensitivity relief3
• Liquid gel formula enables faster fluoride dispersion than pasteform Rx toothpaste1
• Strengthens teeth2
• Reverses early caries2
• Technology shown to significantly remineralize root caries2
• Sensitivity relief and prescription fluoride in one convenient product
• Strengthens teeth2
• Reverses early caries2
• Technology shown to significantly remineralize root caries2
a) by 38% in three months2
Dental
Professional
and patient
Benefits
a) by 38% in three months2
b) by 57% in six months2
• Mild cleaning system with low abrasion
See page 7 for brief summary of information.
To Order: 1.800.372.4346
1
b) by 57% in six months2
• Contains 5% potassium nitrate, clinically proven for sensitivity relief3
• Gentle cleaning system
Colgate® PreviDent® 5000
ENAMEL PROTECT
(Rx Only)
Prescription Strength
Toothpaste
Prescription Strength
Toothpaste for Sensitive Teeth
1.1% sodium fluoride (5000 ppm F-)
• 1.1% sodium fluoride (5000 ppm F-)
• 5% potassium nitrate
• Medium to high caries risk
• Patient requires gentle toothpaste formulation
• Hypersensitivity resulting from enamel wear
• Medium to high caries risk
• Fluoride inhibits demineralization of dental enamel, stimulates
remineralization and reduces acid production in plaque
• Liquid gel formula enables faster fluoride dispersion than pasteform Rx toothpaste1
• Fluoride strengthens enamel and makes teeth more resistant to
acid attacks
• Potassium nitrate desensitizes the pulpal nerve endings to provide
clinically proven sensitivity relief3
• Liquid gel formula enables faster fluoride dispersion than pasteform Rx toothpaste1
• Strengthens teeth2
• Reverses early caries2
• Technology shown to significantly remineralize root caries2
a) by 38% in three months2
• Strengthens teeth and helps protect against acid wear5
• Clinically proven technology to increase resistance to enamel
erosion by over 50% vs Sensodyne® ProNamel™5
• Technology shown to significantly remineralize root caries2
b) by 57% in six months2
a) by 38% in three months2
b) by 57% in six months2
• SLS free formula
• Gentle cleaning system
• Soothing mint flavor formulated to appeal to dry mouth sufferers4
• Contains 5% potassium nitrate, clinically proven for sensitivity relief3
• Mild cleaning system with low abrasion
* Formulated for dry mouth sufferers
Sensodyne® is a registered trademark of GlaxoSmithKline
CAVITY PROTECTION / SENSITIVITY RELIEF
Colgate® PreviDent® 5000
DRY MOUTH*
(Rx Only)
www.colgateprofessional.com
2
AT-HOME
FLUORIDE
Neutral Sodium Fluorides
Colgate® PreviDent® 5000
PLUS
(Rx Only)
Colgate® PreviDent®
GEL
(Rx Only)
Prescription Strength Toothpaste
Prescription Strength Toothpaste
Active
Ingredient
1.1% sodium fluoride (5,000 ppm F-)
1.1% sodium fluoride (5,000 ppm F-)
Patient
Condition
• Medium to high caries risk
• Root exposure
• Medium to high caries risk
• Root exposure
Mode of Action
Fluoride inhibits demineralization of dental enamel, stimulates
remineralization and reduces acid production in plaque
Fluoride inhibits demineralization of dental enamel, stimulates
remineralization, and reduces acid production in plaque
• Strengthens teeth2
• Reverses early root caries2
• Technology shown to significantly remineralize root caries2
• Provides an effective second fluoride treatment after brushing
with a fluoride toothpaste
• Up to 91% arrestment of early root caries6
• Can be delivered via custom mouth tray, for patients who have
difficulty brushing
• Pleasant flavor improves patient compliance
• Safe for porcelain crowns & composite restorations
Dental
Professional
and patient
Benefits
a) by 38% in three months2
b) by 57% in six months2
• Mild cleaning system with low abrasion
• Safe for restorations and ceramic crowns
See page 7 for brief summary of information.
To Order: 1.800.372.4346
3
®
When should you recommend a Colgate®
PreviDent® 5000 Rx product?
Reduces caries up to 55%
0.2% sodium fluoride (900 ppm F-)
• Medium to high caries risk
• Difficulty brushing
Fluoride inhibits demineralization of dental enamel, stimulates
remineralization, and reduces acid production in plaque
GINGIVAL
RECESSION
with exposure of
root surfaces.
ORTHODONTIC
TREATMENT
increases the number
of sites where plaque
can accumulate.
RESTORATIONS
might harbor bacteria
at their margin,
putting them at risk for
recurrent decay.
PERIODONTAL
TREATMENT
might leave dentin
exposed with a
increased risk of dentin
hypersensitivity and
root caries.
DRY MOUTH
significantly
increases the risk of
rampant caries.
ACID EROSION
might expose
dentin, leading to
hypersensitivity.
Liquid gel formula enables faster fluoride dispersion vs.
paste form toothpaste8
•
•
•
•
•
•
Provides 4 times the fluoride of an OTC rinse
Up to 55% caries reduction with weekly use7
Once weekly regimen helps to improve patient compliance
Pleasant cool mint flavor
Once weekly regimen for ease of use
Safe for all types of restorations
ppm Fluoride Release
4500
4000
+26%
3500
PreviDent® 5000
Liquid Gel Dentifrice
5,000 ppm Toothpaste
3000
2500
2000
1500
1000
500
0
0
5
10
15
20
Time (Seconds)
25
30
CAVITY PROTECTION / SENSITIVITY RELIEF
Colgate PreviDent
RINSE
(Rx Only)
®
www.colgateprofessional.com
4
OVER THE
COUNTER
Stannous Fluorides
Colgate® Gel-Kam®
GEL
Colgate® Phos-Flur®
RINSE
Preventative Treatment Gel
for Cavity Protection & Sensitive Teeth
Anticavity Dental
Rinse
Active
Ingredient
0.4% stannous fluoride (970 ppm F-)
0.044% sodium fluoride in an acidulated phosphate solution
(200 ppm F-)
Patient
Condition
• Medium to high caries risk
• Hypersensitivity due to exposed dentin
• Prevention of decay
• Orthodontic decalcification
• Caries risk
Mode of Action
• The anti-bacterial effect of stannous ions helps prevent plaque
formation and the fluoride helps to control caries9
• Stannous fluoride helps form a tin-rich surface deposit to occlude
open dentin tubules9
Acidulated phosphate fluoride solution creates microscopic calcium
fluoride reservoirs; lowered pH allows for enhanced uptake and
retention of fluoride in enamel
Dental
Professional
and patient
Benefits
• 0.4% stannous fluoride strengthens and remineralizes the enamel
• Provides an effective second fluoride treatment after brushing with
a fluoride toothpaste
• Enhanced protection against caries versus toothpaste alone10
• Clinically proven to help prevent caries11
• Reduces white spots by up to 58%12
• Remineralizes teeth by forming microscopic reservoirs of fluoride
on the tooth’s enamel13
• ADA Seal
• Choice of pleasant flavors
See page 7 for brief summary of information.
To Order: 1.800.372.4346
5
Acidulated Phosphate Fluorides
Colgate® PreviDent®
VARNISH
(Rx Only)
Braces may lead to white spots.
Help to reduce the appearance of white
spots with Colgate® Phos-Flur® Rinse.12
5% sodium fluoride (22,600 ppm F-)
• Dentin hypersensitivity
• Post periodontal surgery
• Medium to high caries risk*
• Post scaling / root planing
• Root exposure
Deposition of significant amounts of calcium fluoride that inhibit dentin fluid flow and
provide a reservoir of fluoride ions
• Ready-to-use unit dose treatment
• Highest fluoride concentration available (22,600 ppm F-) as compared to n
on-varnish fluorides
• Provides high concentration of fluoride at the enamel and exposed dentin surface
• Dries transparent on teeth
• Contains xylitol, a natural sweetener
* Use of fluoride varnish for caries prevention has been endorsed by the ADA Council of Scientific Affairs.
Although FDA has cleared fluoride varnishes to be used as cavity varnishes/liners and for the treatment of
hypersensitive teeth, caries prevention is an “off-label” use because FDA has not cleared it for this purpose.15
Available in:
Colgate® Phos-Flur® Rinse provides a unique
acidulated phosphate fluoride solution:
Shown in a clinical study to provide
greater fluoride uptake & deeper
fluoride penetration14
Clinically proven to help prevent caries11
Contains phosphate to help build
strong teeth
CAVITY PROTECTION / SENSITIVITY RELIEF
IN-OFFICE
FLUORIDE
Neutral Sodium Fluorides
www.colgateprofessional.com
6
This is a brief summary of the prescribing information, for full
prescribing information please visit www.colgateprofessional.com
®
®
DESCRIPTION: Self-topical neutral
fluoride toothpaste containing 1.1% (w/w) sodium fluoride®for use
®
as a dental caries preventive in adults and pediatric patients.
®
1.1% Sodium Fluoride
®
DESCRIPTION: Self-topical neutral
fluoride toothpaste containing 1.1% (w/w) sodium
®
fluoride and 5% potassium nitrate.
®
®
Active Ingredient: Sodium fluoride (NaF) PRESCRIPTION
1.1% (w/w) STRENGTH TOOTHPASTE
®
®
®
Active Ingredients: Sodium fluoride
1.1% (w/w),Potassium nitrate 5%
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for
twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity
of the teeth
cold, heat,
acids, sweets or contact in adult patients and children
12 yearsFluoride
1.1% to
Sodium
Fluoride
1.1% Sodium
*Formulated
Mouth established
Sufferers
of age and
older.forItDry
is well
that 1.1% sodium fluoride is safe and extraordinarily
PRESCRIPTION
1-4STRENGTH TOOTHPAS
effective
as
a
caries
preventive
when
applied
frequently
with
mouthpiece
applicators.
PRESCRIPTION STRENGTH TOOTHPASTE
PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH
PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium
nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste
should be used twice daily in place of your regular toothpaste unless otherwise instructed
0.2% Neutral Sodium Fluo
% used
Sodium
Fluoride
% Sodium
by your dental professional. May1.1be
in areas
where drinking water is fluoridated1.1
since
topical Fluoride
fluoride cannot produce fluorosis. (See
WARNINGS
for exception.)
PRESCRIPTION STRENGTH TOOTHPASTE
Non-abrasive formula is gentle
SENSITIVE
DRY MOUTH
1.1% Sodium Fluoride
5% Potassium Nitrate
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is
well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive
when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Booster brand of 1.1%
1.1% Sodium Fluoride
1.1% Sodium Fluoride
1.1% Sodium Fluoride
sodium fluoride
toothpaste
in a squeeze bottle is easily applied onto a toothbrush.
This
*Formulated for
Dryprescription
Mouth Sufferers
5% Potassium
Nitrate
PRESCRIPTION STRENGTH TOOTHPASTE
toothpaste should be used once daily in place of your regular toothpaste unless
otherwise instructed
PRESCRIPTION STRENGTH TOOTHPASTE
on teeth and gums
PRESCRIPTION STRENGTH
by your dental
professional.
May
be
used
in
areas
where
drinking
water
is
fluoridated since topical
TOOTHPASTE FOR SENSITIVE TEETH
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
fluoride cannot produce fluorosis. (See WARNINGS for exception.)
WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water
use this product longer than 4 weeks unless recommended by a dentist or physician.
fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric
patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under
PRECAUTIONS:
age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
PRECAUTIONS:
female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in
General: Not for systemic treatment. DO NOT SWALLOW.
male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats
fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally
treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5
occurring or added to drinking water, and risk of human cancer.
and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in
Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human
chromosome damage in rodents, while other studies using similar protocols report negative results.
and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents,
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported
while other studies using similar protocols report negative results.
for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats,
demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is
12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the
incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight
frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological
(rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There
studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero
are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water
development may result in skeletal fluorosis which becomes evident in childhood.
showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products
when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals
containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a
were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring
high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to
were seen in rats administered fluoride up to 5 mg/kg of body weight.
5 mg/kg of body weight.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the
Pediatric Use: The use of PreviDent® 5000 Booster in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1%
CONTRAINDICATIONS and WARNINGS sections.
sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/w) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are
useful to monitor renal function.5
more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5
SENSITIVE
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may
occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may
persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally
to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight)
have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical
assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit
immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Booster contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 608
mg fluoride.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion. (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium
lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9
mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains
approximately 575 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
1.Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000
Booster to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime,
in place of your regular toothpaste.
2.After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes.
Pediatric patients, ages 6-16 years of age, expectorate after use and rinse mouth thoroughly.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth
thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or
physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.
Rev. 11/08
To Order: 1.800.372.4346
7
DRY MOUTH
Rev. 11/08
®
DESCRIPTION: Self-topical neutral fluoride toothpaste containing
1.1% (w/w) sodium fluoride for
use as a dental caries preventative in adults and pediatric patients.
®
®
DRY MOUTH
1.1% Sodium Fluoride
*Formulated for Dry Mouth Sufferers
PRESCRIPTION STRENGTH TOOTHPASTE
Active Ingredient: Sodium fluoride 1.1% (w/w)
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use.
It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries
1-4
®
preventive
when
applied
frequently with mouthpiece
applicators.
PreviDent
5000 Dry Mouth
1.1% Sodium
Fluoride
1.1%
Sodium
Fluoride
1.1% Sodium
Fluoride
brand of 1.1% sodium fluoride toothpastePRESCRIPTION
in a squeezeSTRENGTH
bottle is TOOTHPASTE
easily applied onto a toothbrush.
PRESCRIPTION STRENGTH TOOTHPASTE
Non-abrasive formula is gentle
This prescription
toothpaste should be used once daily in place
of
your
regular
toothpaste unless
on teeth and gums
otherwise instructed by your dental professional. May be used in areas where drinking water is
fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water
fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric
patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients
under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female
rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated
with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of
body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and
risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured
human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage
in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for
rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated
that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of
skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in
areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in
skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a
diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats
administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® 5000 Dry Mouth in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies
with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients
below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and
over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has
not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug
is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
DESCRIPTION: Self-topical®neutral fluoride toothpaste containing 1.1% (w/w) sodium
fluoride and 5% potassium nitrate.
®
®
®
ENAMEL PROTECT
0.2%
Neutral
Sodium Fluoride
1.1%
Sodium
Fluoride
5% Potassium Nitrate
PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH
®
Active Ingredients: Sodium fluoride
1.1%(w/w), Potassium nitrate 5%
Inactive Ingredients: water, hydrated silica, sorbitol, PEG-12, sodium lauryl sulfate,
DRY MOUTH
carrageenan,
dioxide,
sodium
0.63%
Stannousflavor, poloxamer 407, cocamidopropyl
0.4%betaine,
Stable titanium
Stannous
Fluoride
Fluoride
Concentrate
saccharin,
mica, sodium hydroxide
PREVENTATIVE TREATMENT GEL 1.1% Sodium Fluoride
1.1% Sodium Fluoride
Acidulat
ORAL CARE RINSE
*Formulated for Dry Mouth Sufferers
CLINICAL PHARMACOLOGY: Frequent topical applications to the teeth with
preparations
PRESCRIPTION
STRENGTH TOOTHP
STRENGTH TOOTHPASTE
havingPRESCRIPTION
a relatively high
fluoride content increase tooth resistance to acid dissolution and
enhance penetration of the fluoride ion into tooth enamel.
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for
twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult
patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive
when applied frequently with mouthpiece applicators.1-4 PreviDent® Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in
a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless
otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
(See WARNINGS for exception.)
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist
or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not
use this product longer than 4 weeks unless recommended by a dentist or physician.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
female thers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed
a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in
rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the
CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function.5
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium
lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg
fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Enamel Protect contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains
approximately 591 mg fluoride.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea
may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms
may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk)
orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body
weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek
medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting
and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Dry Mouth contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately
608 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
1. Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Enamel Protect onto a soft bristle toothbrush.
Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly.
2. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
Children under 12 years of age: Consult a dentist or physician.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Dry Mouth to a toothbrush.
Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste.
2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes.
Pediatric patients, ages 6-16 years of age, expectorate after use and rinse mouth thoroughly.
STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C)
Rev. 11/08
HOW SUPPLIED:
3.4 FL OZ (100 mL) in plastic bottles.
Mint: NDC 0126-0022-92
REFERENCES: 1. American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407. 2. H.R. Englander et al., JADA 75
(1967): 638-644. 3. H.R. Englander et al., JADA 78 (1969): 783-787. 4. H.R. Englander et al., JADA 83 (1971): 354-358. 5. Data on file, Colgate Oral
Pharmaceuticals.
Rev. 12/10
www.colgateprofessional.com
8
®
DESCRIPTION: Self-topical
neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a
dental caries preventive in adults and pediatric patients.
®
®
NSITIVE
1.1% Sodium Fluoride
Sodium Fluoride
Potassium Nitrate
PRESCRIPTION STRENGTH TOOTHPASTE
RIPTION STRENGTH
HPASTE FOR SENSITIVE TEETH
for exception.)
®
ACTIVE INGREDIENT: Sodium
Fluoride 1.1% (w/w).
ACTIVE INGREDIENTS: Sodium Fluoride (NaF) 1.1% (w/v).
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well
established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when
®
®
Neutral
Sodium
Fluoride
applied
frequently
withFluoride
mouthpiece applicators.1-4 PreviDent0.2%
50001.1
Plus
brand
ofFluoride
1.1%
sodium fluoride in
1.1% Sodium
1.1% Sodium
Fluoride
% Sodium
for Dry Mouth
Sufferers
a*Formulated
squeeze-tube
is easily
applied onto a toothbrush. This prescription dental cream should be used once daily
Non-abrasive formula is gentle
PRESCRIPTION STRENGTH TOOTHPASTE
in
place of
regular
toothpaste unless otherwise instructed by your dental professional. May be used in
on your
teeth
and
gumsTOOTHPASTE
PRESCRIPTION
STRENGTH
areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS
INDICATIONS
USAGE:
A dental caries preventive, for once daily self-applied topical use. It is well
0.4% StableAND
Stannous
Fluoride
0.63% Stannous
established that 1.1% sodium fluoride is safe and extraordinarily
effective
as a caries preventive when
Fluoride
Concentrate
PREVENTATIVE
®
0.2%TREATMENT
Neutral
Sodium Fluoride
5% Sodium
Fluoride
applied
frequently
with GEL
mouthpiece
applicators.1-4 PreviDent
Gel in aFluoride
squeeze-tube
is easily
applied onto
a
Acidulated Phosphate
ORAL CARE
RINSE Solution
toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use
of a regular toothpaste unless otherwise instructed by your dental professional.
DRY MOUTH
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water
fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in
pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read
directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male
rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up
to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added
to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential
to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are
conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse
reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox,
and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that
lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of
skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted
in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may
result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed
a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in
rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® 5000 Plus® in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies
with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients
below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/w) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function.5
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium
lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg
fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Plus® contains
2.5 mg fluoride. A 1.8 oz. tube contains 255 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Plus® to a toothbrush.
Brush thoroughly once daily for two minutes, preferably at bedtime.
2.After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes.
Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.
REV 05/03
To Order: 1.800.372.4346
9
DESCRIPTION: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries
preventive in pediatric patients and adults. This prescription product is not a dentifrice.
0.63% Stannous
Fluoride Concentrate
1.1%
Sodium Fluoride
ORAL CARE
RINSE
Non-abrasive formula is gentle
on teeth and gums
or physician.
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas
with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing
of gel. Read directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male
rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up
to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added
to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in
cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report
chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride
exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm
or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5
mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of
skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted
in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may
result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed
a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in
rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® Brush-On Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies
with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients
below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function.
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
Overdosage: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium
lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9
mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® Gel contains
approximately 2 mg fluoride. A 0.8 oz. tube contains approximately 104 mg fluoride. A 2 oz. tube contains approximately 266 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
1. After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth
with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime.
2. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes.
Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.
REV 05/03
0.4% Sta
PREVENTATIV
DESCRIPTION: PreviDent® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous
solution containing 6% alcohol.
DESCRIPTION: Gel-Kam® brand of stannous fluoride Oral Care Rinse is a stable, water-free concentrate
containing 0.63% stannous fluoride for dilution to 0.1% stannous fluoride. This is a treatment rinse, not a
mouthwash.
Active Ingredient: Sodium Fluoride 0.2% (w/v).
INDICATIONS AND USAGE: A dental caries preventive, for weekly self-applied topical use. Weekly rinsing
0.63%
Stannous
Stannous
with a neutral
0.2%
sodium fluoride solution protects against0.4%
dentalStable
caries in
pediatricFluoride
patients. PreviDent®
Fluoride Concentrate
PREVENTATIVE
TREATMENT
GEL compliance.
0.2%
Neutral
Sodium Fluoride
Rinse provides a ready-to-use
preparation
and
favorable
May
0.2% Neutral
1.1% Sodium
Sodium Fluoride
Fluoride
1.1% Sodium
Fluoridefor convenient administration
ORAL CARE RINSE
be
used
in
areas
where
drinking
water
is
fluoridated
since
topical
fluoride
cannot
produce
fluorosis. (See
PRESCRIPTION STRENGTH TOOTHPASTE
Non-abrasive formula is gentle
WARNINGS for exception.)
on teeth and gums
Active Ingredient: Stannous fluoride 0.63% (w/w) (provides 0.1% (w/v) stannous fluoride).
0.63% Stannous
Fluoride Concentrate
Acidulated Phosphate
Solution
ORALFluoride
CARE RINSE
CONTRAINDIACTIONS: Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or
physician.
WARNINGS: Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under
age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged
daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before
using.
DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenesis was found in mice or female rats treated with fluoride at doses ranging
from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In
another study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible
evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems but has been associated with chromosome aberrations in cultured human and rodent cells
at doses much higher than expected human exposures. Some in vivo report chromosome damage in rodents while other studies using similar protocols
report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported
for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats
demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect litter size or fetal weight and did not increase frequency of skeletal
or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas
with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in
skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed
a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in
rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® Rinse as a weekly caries preventive in pediatric patients aged 6 to 16 years is supported by adequate and
well-controlled clinical studies in students aged 6 to 12 years.1-3 Safety and effectiveness in pediatric patients below the age of 6 years have not been
established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function.
ADVERSE REACTIONS: In patients with mucositis, gingival tissues may be hypersensitive to flavor or alcohol present in formulation. Allergic reactions
and other idiosyncrasies are rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate
solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg
fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (10 mL or two teaspoonfuls) of PreviDent® Rinse contains approximately 9 mg fluoride. One 16 fl. oz. bottle contains approximately 429
mg fluoride.
DOSAGE AND ADMINISTRATION: For caries — Adults and pediatric patients over age 6 years, 2 teaspoonfuls (10 mL). Once a week, preferably at
bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For
maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.
Rev. 02/09
0.4% Stable Stannous
V ARNFluoride
IS H
INDICATIONS AND USAGE: For daily self-applied topical use as a dental caries preventive. It is well
5% GEL
Sodium Fluoride
PREVENTATIVE TREATMENT
5% Sodium
Fluoride
5% Sodium Fluoride
established
that a 0.1% stannous
fluoride rinse is a convenient
wayPhosphate
to applyFluoride
fluoride
to the surfaces
of
Acidulated
Solution
teeth to aid in the prevention of decalcification and dental caries. This is accomplished by increasing the
resistance of tooth surfaces to acid dissolution.
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician. Not for systemic treatment.
WARNINGS: Pediatric patients under 12 years of age should be supervised in the use of this product. Prolonged daily ingestion may result in various
degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water. Use in pediatric
patients under age 6 required special supervision to prevent repeated swallowing of rinse. Do not use before mixing with water. This product may
produce temporary surface staining of teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by
your dentist. Read directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in mice or female rats treated
with fluoride at doses ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with
2.5 and 4.1 mg/kg of body weight. In another study, no carcinogenesis was observed in rats treated with fluoride up to 11.2 mg/kg of body weight.
Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk
of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion is not mutagenic in standard bacterial systems. It has
been shown that fluoride ion has potential to induce chromosomes aberrations in cultured human and rodent cells at doses much higher than those
to which humans are exposed. In vitro data are conflicting. Some studies report chromosome damage in rodents while other studies using similar
protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were
reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted
in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue.
Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1
mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase frequency of skeletal or visceral malformations. There
are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally
fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which
becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk and caution should be exercised
when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals
were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring
were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of Gel-Kam® Oral Rinse as a weekly caries preventive in pediatric patients aged 12 to 16 years is supported by adequate and
well-controlled study in school children.1 Safety and effectiveness in pediatric patients below the age of 12 have not been established. Please refer to
the CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot
be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function.
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies are rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested,
give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more
than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium
lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9
mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (two one-minute applications) of Gel-Kam® Rinse contains approximately 7.1 mg fluoride. One 10 oz. bottle contains approximately
436 mg fluoride.
DOSAGE AND ADMINISTRATION: Adults and pediatric patients 12 years and older: use at least daily or more often as directed, following regular
brushing and flossing. Pour the concentrated Rinse to the 1/8 fluid ounce mark in the mixing vial (to bottom mark). Add water to the 1 fl. oz. mark
and mix. This prepares a 0.1% (w/v) stannous fluoride rinse. Use immediately after preparing the rinse. Place one half of the solution into the mouth
and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with the remaining solution and expectorate. Pediatric patients
under 12 years of age: consult a dentist or physician. Pediatric patients under 12 years of age should be supervised in the use of this product. For Home
Irrigators: Prepare 1 fl. oz. of Rinse as described above. Pour into irrigator reservoir and add 4 more fluid ounces of water. Mix thoroughly. This prepares
a 0.02% (w/v) stannous fluoride rinse. Use irrigator as directed. Rinse the irrigator with water after use.
Rev. 03/09
www.colgateprofessional.com
10
DESCRIPTION: PreviDent® 5% Sodium Fluoride Varnish contains 22,600 ppm fluoride. It has a strong
desensitizing action when applied to dental surfaces, treating hypersensitivity quickly and easily. This
product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent® Varnish
will leave a thin film on the teeth after application.
ide Solution
5% Sodium Fluoride
COMPOSITION: 1 mL of this suspension contains 50 mg sodium fluoride, equivalent to 22.6 mg fluoride
VARNISH
ion, in an alcoholic solution of natural resins.
5% Sodium Fluoride
INDICATIONS: PreviDent® Varnish is a topical fluoride for the treatment of dentinal and post operative
sensitivity.
Dosage: To be administered by the dental professional for the treatment of dentin hypersensitivity. The fluoride content in this product is dosed in such
a way that neither acute nor chronic side effects are to be expected if applied according to the instructions.
DIRECTIONS FOR USE: Please observe when treating hypersensitive teeth
1.Wash and dry tooth surface.
2.Mix well prior to application.
3.Apply product with supplied brush in the conventional manner.
4.Thin excess varnish on the tooth’s surface until the varnish surface is dry.
5.Covers even moist teeth with a coating of varnish film for several hours which occludes the openings of the dental tubules.
6.Hardens on contact with saliva so the patient may leave immediately after application of the product.
7.It is recommended that the patient be instructed to eat only soft foods for 2 hours after treatment.
CONTRAINDICATIONS: Ulcerative gingivitis and stomatitis.
INTERACTIONS: When PreviDent® Varnish is applied, other fluoride preparations such as fluoride gels should not be administered during the same day.
The routine use of fluoride tablets should be interrupted for several days after treatment.
ADVERSE REACTIONS: Edematous swellings have been reported only in rare instances in some fluoride varnish products, especially after application
to extensive surfaces. Dyspnea, although extremely rare, has occurred in asthmatic children. Nausea has been reported when extensive applications
have been made. If required, varnish film can be removed with a thorough brushing.
Store in a cool, dry place.
Rev. 12/08
At-Home Fluoride
1. Joziak MT et al. Comparison of enamel fluoride uptake and fluoride release from liquid and paste dentifrice. J Dent Res.
2003; 82 (Sp issue). Abstract 1355. 2. Baysan et al, Reversal of primary root caries using dentifrices containing 5000 ppm
and 1100 ppm fluoride. Caries Res, 2001; 35: 41-46. 3. Markowitz K. Arch Oral Biol 1991; 36:1-7 4. Jensen J & Barkvoll
P, Clinical Implication of the Dry Mouth: Oral Mucosal Diseases, Annals NY Acad Sci, Vol 842, 156-162, 1998. 5. Colgate.
Prevention of dental erosion by 5000 ppm fluoride treatment in situ. IADR General Session. 2010. 6. DePaola PF. In: Bowen
WH & Tabak LA (eds.): Cariology for the Nineties. Rochester, University of Rochester Press, 1993, pp 25-35. 7. Driscoll WS, et
al. J Am Dent Assoc 1982; 105: 1010-13.
Over The Counter
8. Joziak MT, et al. Comparison of enamel fluoride uptake and fluoride release from liquid and paste dentifrice. J Dent Res.
2003; 82 (Sp Issue). Abstract 1355. 9. Miller S. Int Dent J 1994; 44(1 Suppl 1): 83-98. 10. Boyd RL. Int Dent J 1994; 44(1
Suppl 1): 119-130. 11. Marinho VCC et al. Fluoride mouthrinses for preventing dental caries in children and adolescents.
The Cochrane Library 2007. Issue 3. 12. Hirschfield RE. J Dent Child 1978; 45: 458-460. 13. Keyes, P. and Englander HR,
Fluoride therapy in the treatment of dentomicrobial plaque diseases. JOSPD 1975; 16-45. 14. Aasenden R et al. Archs Oral
Biol 1972; 17:1705-1714.
Distributed by: Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company,
New York, NY 10022 U.S.A.
In-Office Fluoride
Questions / Comments: 1-800-962-2345
15. ADA Council of Scientific Affairs. J Am Dent Assoc 2006; 137: 1151-1159
or call 1-800-2COLGATE
to speak to your Oral Care
Consultant today
To Order: 1.800.372.4346
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©2012 Colgate Oral Pharmaceuticals, a subsidiary of Colgate-Palmolive Company, New York, NY 10022, USA
01/2012
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