Download HIGHLIGHTS OF PRESCRIBING INFORMATION These

16 HOW SUPPLIED/STORAGE AND HANDLING
(OW3UPPLIED
3TORAGE#ONDITIONS
17 PATIENT COUNSELING INFORMATION
3ECTIONSORSUBSECTIONSOMITTEDFROMTHEFULLPRESCRIBINGINFORMATIONARE
NOTLISTED
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VUSION
Ointment safely and effectively. See full prescribing information for
VUSION Ointment.
VUSION® (miconazole nitrate, zinc oxide, and white petrolatum) Ointment,
for topical use only
Initial U.S. Approval: 2006
------------------------------INDICATIONS AND USAGE -----------------------------s 653)/./INTMENTISINDICATEDFORADJUNCTIVETREATMENTOFDIAPER
DERMATITISWHENCOMPLICATEDBYDOCUMENTEDCANDIDIASISMICROSCOPIC
EVIDENCEOFPSEUDOHYPHAEANDORBUDDINGYEASTINIMMUNOCOMPETENT
PEDIATRICPATIENTSWEEKSANDOLDER
s 653)/./INTMENTSHOULDNOTBEUSEDASASUBSTITUTEFORFREQUENTDIAPER
CHANGES
s 653)/./INTMENTSHOULDNOTBEUSEDTOPREVENTTHEOCCURRENCEOF
DIAPERDERMATITISSINCEPREVENTATIVEUSEMAYRESULTINTHEDEVELOPMENT
OFDRUGRESISTANCE
-------------------------- DOSAGE AND ADMINISTRATION -------------------------s 653)/./INTMENTISFORTOPICALUSEONLY653)/./INTMENTISNOTFOR
ORALOPHTHALMICORINTRAVAGINALUSE
s 653)/./INTMENTSHOULDBEAPPLIEDASATHINLAYERTOTHEAFFECTEDAREA
ATEACHDIAPERCHANGEFORDAYS
s 653)/./INTMENTSHOULDBEUSEDASPARTOFATREATMENTREGIMENTHATIN
CLUDESGENTLECLEANSINGOFTHEDIAPERAREAANDFREQUENTDIAPERCHANGES
------------------------ DOSAGE FORMS AND STRENGTHS -----------------------s /INTMENTWITHMICONAZOLENITRATEZINCOXIDEAND
WHITEPETROLATUM
-------------------------------- CONTRAINDICATIONS -------------------------------s .ONE
-------------------------- WARNINGS AND PRECAUTIONS -------------------------s )FIRRITATIONOCCURSORIFTHEDISEASEWORSENSDISCONTINUEUSEOFTHE
MEDICATIONANDCONTACTTHEHEALTHCAREPROVIDER
-------------------------------- ADVERSE REACTIONS -------------------------------To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc.
at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient
labeling.
Revised: 10/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1
INDICATIONS AND USAGE
)NDICATION
,IMITATIONSOF5SE
2
DOSAGE AND ADMINISTRATION
3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
6
ADVERSE REACTIONS
#LINICAL4RIALS%XPERIENCE
0OSTMARKETING%XPERIENCE
7
DRUG INTERACTIONS
8
USE IN SPECIFIC POPULATIONS
0REGNANCY
.URSING-OTHERS
0EDIATRIC5SE
'ERIATRIC5SE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
-ECHANISMOF!CTION
0HARMACODYNAMICS
0HARMACOKINETICS
-ICROBIOLOGY
13 NONCLINICAL TOXICOLOGY
#ARCINOGENESIS-UTAGENESIS)MPAIRMENTOF&ERTILITY
14 CLINICAL STUDIES
Page 1
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
1.1 Indication
653)/./INTMENTISINDICATEDFORTHEADJUNCTIVETREATMENTOFDIAPER
DERMATITISONLYWHENCOMPLICATEDBYDOCUMENTEDCANDIDIASISMICROSCOPIC
EVIDENCEOFPSEUDOHYPHAEANDORBUDDINGYEASTINIMMUNOCOMPETENT
PEDIATRICPATIENTSWEEKSANDOLDER!POSITIVEFUNGALCULTUREFORCandida
albicansISNOTADEQUATEEVIDENCEOFCANDIDALINFECTIONSINCECOLONIZATIONWITH
C. albicansCANRESULTINAPOSITIVECULTURE4HEPRESENCEOFCANDIDALINFECTION
SHOULDBEESTABLISHEDBYMICROSCOPICEVALUATIONPRIORTOINITIATINGTREATMENT
653)/.SHOULDBEUSEDASPARTOFATREATMENTREGIMENTHATINCLUDES
MEASURESDIRECTEDATTHEUNDERLYINGDIAPERDERMATITISINCLUDINGGENTLECLEANS
INGOFTHEDIAPERAREAANDFREQUENTDIAPERCHANGES
VUSION should not be used as a substitute for frequent diaper
changes. VUSION should not be used to prevent the occurrence of diaper
dermatitis, since preventative use may result in the development of drug
resistance.
1.2 Limitations of Use
4HESAFETYANDEFFICACYOF653)/.HAVENOTBEENDEMONSTRATEDINIM
MUNOCOMPROMISEDPATIENTSORININFANTSLESSTHANWEEKSOFAGEPREMATURE
ORTERM
4HESAFETYANDEFFICACYOF653)/.HAVENOTBEENEVALUATEDININCONTI
NENTADULTPATIENTSVUSION should not be used to prevent the occurrence of
diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
2
DOSAGE AND ADMINISTRATION
653)/.ISNOTFORORALOPHTHALMICORINTRAVAGINALUSE
"EFOREAPPLYING653)/.GENTLYCLEANSETHESKINWITHLUKEWARMWATER
ANDPATDRYWITHASOFTTOWEL!VOIDUSINGANYSCENTEDSOAPSSHAMPOOSOR
LOTIONSONTHEDIAPERAREA
!PPLY653)/.TOTHEAFFECTEDAREAATEACHDIAPERCHANGEFORDAYS
#ONTINUETREATMENTFORTHEFULLDAYSEVENIFTHEREISIMPROVEMENT4HE
SAFETYOF653)/.WHENUSEDFORLONGERTHANDAYSISNOTKNOWN$ONOTUSE
653)/.FORLONGERTHANDAYS)FSYMPTOMSHAVENOTIMPROVEDBYDAYSEE
YOURHEALTHCAREPROVIDER
'ENTLYAPPLYATHINLAYEROF653)/.TOTHEDIAPERAREAWITHTHEFINGER
TIPS$ONOTRUB653)/.INTOTHESKINASTHISMAYCAUSEADDITIONALIRRITATION
4HOROUGHLYWASHHANDSAFTERAPPLYING653)/.
3
DOSAGE FORMS AND STRENGTHS
7HITEOINTMENTCONTAININGMICONAZOLENITRATEZINCOXIDE
ANDWHITEPETROLATUM
4
CONTRAINDICATIONS
.ONE
5
WARNINGS AND PRECAUTIONS
)FIRRITATIONOCCURSORIFTHEDISEASEWORSENSDISCONTINUEUSEOFTHE
MEDICATIONANDCONTACTTHEHEALTHCAREPROVIDER
4HESAFETYANDEFFICACYOF653)/.HAVENOTBEENEVALUATEDININCONTI
NENTADULTPATIENTSVUSION should not be used to prevent the occurrence of
diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
6
ADVERSE REACTIONS
6.1 Clinical Trials Experience
"ECAUSECLINICALTRIALSARECONDUCTEDUNDERWIDELYVARYINGCONDITIONS
ADVERSEREACTIONRATEOBSERVEDINTHECLINICALTRIALSOFADRUGCANNOTBEDIRECTLY
COMPAREDTORATESINTHECLINICALTRIALSOFANOTHERDRUGANDMAYNOTREFLECTTHE
RATESOBSERVEDINCLINICALPRACTICE
!TOTALOFINFANTSANDYOUNGCHILDRENWEREEVALUATEDINTHECLINICAL
DEVELOPMENTPROGRAM/FSUBJECTSINTHE653)/.GROUP
REPORTEDONEORMOREADVERSEEVENTS/FSUBJECTSINTHEZINCOXIDEWHITE
PETROLATUMCONTROLGROUPREPORTEDONEORMOREADVERSEEVENTS
!DVERSEEVENTSTHATOCCURREDATARATEOF≥FORSUBJECTSWHOWERETREATED
WITH653)/.WEREAPPROXIMATELYTHESAMEINTYPEANDFREQUENCYASFOR
SUBJECTSWHOWERETREATEDWITHZINCOXIDEWHITEPETROLATUMOINTMENT
Page 2
6.2 Post-marketing Experience
4HEFOLLOWINGADVERSEREACTIONSHAVEBEENIDENTIFIEDDURINGPOSTAP
PROVALUSEOF653)/.
GASTROINTESTINAL DISORDERS:VOMITING
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS:BURNING
SENSATIONCONDITIONAGGRAVATEDINFLAMMATIONPAIN
INJURY, POISONING AND PROCEDURAL COMPLICATIONS:ACCIDENTALEXPOSURE
SKIN AND SUBCUTANEOUS TISSUE DISORDERS:BLISTERDERMATITISCONTACT
DIAPERDERMATITISDRYSKINERYTHEMAPRURITUSRASHSKINEXFOLIATION
"ECAUSETHESEREACTIONSAREREPORTEDVOLUNTARILYFROMAPOPULATIONOF
UNCERTAINSIZEITISNOTALWAYSPOSSIBLETORELIABLYESTIMATETHEIRFREQUENCYOR
ESTABLISHACAUSALRELATIONSHIPTODRUGEXPOSURE
7
DRUG INTERACTIONS
$RUGDRUGINTERACTIONSTUDIESWERENOTCONDUCTED7OMENWHOTAKEA
WARFARINANTICOAGULANTANDUSEAMICONAZOLEINTRAVAGINALCREAMORSUPPOSI
TORYMAYBEATRISKFORDEVELOPINGANINCREASEDPROTHROMBINTIMEINTERNA
TIONALNORMALIZEDRATIO).2ANDBLEEDING4HEPOTENTIALFORTHISINTERACTION
BETWEENWARFARINAND653)/.ISUNKNOWN
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
4HEMICONAZOLECOMPONENTOF653)/.ISANANTIFUNGALAGENT;SEE#LINI
CAL0HARMACOLOGY=4HEMECHANISMOFACTIONOFWHITEPETROLATUMAND
ZINCOXIDEFORTHEADJUNCTIVETREATMENTOFDIAPERDERMATITISISUNKNOWN
12.2 Pharmacodynamics
4HEHUMANPHARMACODYNAMICSOF6USIONISUNKNOWN;SEE#LINICAL
0HARMACOLOGYFORFUNGALPHARMACODYNAMICS=
12.3 Pharmacokinetics
4HETOPICALABSORPTIONOFMICONAZOLEFROM653)/.WASSTUDIEDIN
IMMUNOCOMPETENTMALEANDFEMALEINFANTSANDCHILDRENNWITHDIAPER
DERMATITISCOMPLICATEDBYDOCUMENTEDCANDIDIASISMICROSCOPICEVIDENCE
OFPSEUDOHYPHAEANDORBUDDINGYEASTRANGINGINAGEFROMMONTHTO
MONTHS!FTERMULTIPLEDAILYAPPLICATIONSTOTHEAFFECTEDAREAATEVERYDIAPER
CHANGEAPPROXIMATELYTIMESPERDAYFORDAYSTHEPLASMACONCENTRA
TIONSOFMICONAZOLEWEREBELOWTHELOWERLIMITOFQUANTITATION,/1OF
NGM,INOUTOFSUBJECTS)NTHEOTHERREMAININGSUBJECTSTHE
PLASMACONCENTRATIONSOFMICONAZOLEWEREANDNGM,RESPECTIVELY
ATASINGLETIMEPOINTHOURSAFTERTHELASTAPPLICATIONON$AY
8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
4HEREARENOADEQUATEANDWELLCONTROLLEDSTUDIESOF653)/.INPREG
NANTWOMEN4HEREFORE653)/.SHOULDBEUSEDDURINGPREGNANCYONLYIFTHE
POTENTIALBENEFITJUSTIFIESTHEPOTENTIALRISKTOTHEFETUS
-ICONAZOLENITRATEADMINISTRATIONHASBEENSHOWNTORESULTINPROLONGED
GESTATIONANDDECREASEDNUMBERSOFLIVEYOUNGINRATSANDININCREASEDNUMBER
OFRESORPTIONSANDDECREASEDNUMBEROFLIVEYOUNGINRABBITSATORALDOSESOF
MGKGDAYANDMGKGDAYWHICHAREANDTIMESTHEMAXIMUM
POSSIBLETOPICALEXPOSUREOFCAREGIVERSRESPECTIVELYASSUMINGABSORPTION
12.4 Microbiology
4HEMICONAZOLENITRATECOMPONENTINTHISPRODUCTHASBEENSHOWNTO
HAVEin vitroACTIVITYAGAINSTCandida albicans,ANORGANISMTHATISASSOCIATED
WITHDIAPERDERMATITIS4HEACTIVITYOFMICONAZOLENITRATEAGAINSTC. albicansIS
BASEDONTHEINHIBITIONOFTHEERGOSTEROLBIOSYNTHESISINTHECELLMEMBRANE
4HEACCUMULATIONOFERGOSTEROLPRECURSORSANDTOXICPEROXIDESRESULTSINCY
TOLYSISOFTHECELLIn vitroMINIMALINHIBITORYCONCENTRATION-)#TESTRESULTS
FORC. albicansISOLATESOBTAINEDFROMTREATMENTFAILURESIN#LINICAL3TUDY
see Clinical Studies (14)DOESNOTAPPEARTOINDICATETHATRESISTANCETOMI
CONAZOLENITRATEWASTHEREASONFORTREATMENTFAILURE4HECLINICALSIGNIFICANCE
OFTHEin vitroACTIVITYOFMICONAZOLENITRATEAGAINSTC. albicansINTHESETTINGOF
DIAPERDERMATITISISUNCLEAR
8.3 Nursing Mothers
3AFETYANDEFFICACYOF653)/.HAVENOTBEENESTABLISHEDINNURSING
MOTHERS)TISNOTKNOWNIFTHEACTIVECOMPONENTSOF653)/.MAYBEPRESENT
INMILK
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
4HECARCINOGENICPOTENTIALOF653)/.INANIMALSHASNOTBEENEVALUATED
-ICONAZOLENITRATEWASNEGATIVEINABACTERIALREVERSEMUTATIONTESTA
CHROMOSOMEABERRATIONTESTINMICEANDMICRONUCLEUSASSAYSINMICEANDRATS
-ICONAZOLENITRATEHADNOADVERSEEFFECTONFERTILITYINASTUDYINRATSAT
ORALDOSESOFUPTOMGKGDAYWHICHISTIMESTHEMAXIMUMPOSSIBLE
TOPICALEXPOSUREOFCAREGIVERSASSUMINGABSORPTION
8.4 Pediatric Use
%FFICACYWASNOTDEMONSTRATEDININFANTSLESSTHANWEEKSOFAGE
3AFETYANDEFFICACYHAVENOTBEENESTABLISHEDINVERYLOWBIRTHWEIGHTINFANTS
653)/.SHOULDNOTBEUSEDTOPREVENTDIAPERDERMATITIS
4HESAFETYOF653)/.WHENUSEDFORLONGERTHANDAYSISNOTKNOWN
$ONOTUSEMORETHANDAYS
8.5 Geriatric Use
3AFETYANDEFFICACYINAGERIATRICPOPULATIONHAVENOTBEENEVALUATED
11 DESCRIPTION
653)/.CONTAINSTHESYNTHETICANTIFUNGALAGENTMICONAZOLENITRATE
530ZINCOXIDE530ANDWHITEPETROLATUM530
4HECHEMICALNAMEOFMICONAZOLENITRATEIS;DICHLORO”[
DICHLOROBENZYLOXY]PHENETHYL=IMIDAZOLEMONONITRATEWITHEMPIRICALFORMULA
#(#L./s(./ANDMOLECULARWEIGHTOF4HESTRUCTURALFORMULAOF
MICONAZOLENITRATEISASFOLLOWS
14 CLINICAL STUDIES
3TUDYWASADOUBLEBLINDMULTICENTERSTUDYINWHICH653)/.WAS
COMPAREDTOTHEZINCOXIDEANDWHITEPETROLATUMCOMBINATIONTREATMENTAND
INCLUDEDINFANTSANDTODDLERSWITHDIAPERDERMATITISCOMPLICATEDBY
CANDIDIASISASDOCUMENTEDBY+/(TESTSTHATDEMONSTRATEDPSUEDOHYPHAE
ANDORBUDDINGYEASTS3TUDYMEDICATIONWASAPPLIEDATEVERYDIAPERCHANGE
FORDAYS
4HEPRIMARYENDPOINTWASh/VERALL#UREvANDREQUIREDTHATSUBJECTSBE
BOTHCLINICALLYCUREDTOTALRESOLUTIONOFALLSIGNSANDSYMPTOMSOFINFECTION
ANDMICROBIOLOGICALLYCUREDERADICATIONOFCANDIDIASIS0RIMARYEFFICACYWAS
ASSESSEDWEEKFOLLOWINGTHEENDOFTREATMENTAT$AY
3TUDYRESULTSARESHOWNINTHEFOLLOWINGTABLE
/VERALL#UREAT$AY
ANDENANTIOMER(./
3TRUCTURALFORMULAOFMICONAZOLENITRATE
4HEZINCOXIDEHASANEMPIRICALFORMULAOF:N/ANDAMOLECULARWEIGHT
OF
4HEWHITEPETROLATUMWHICHISOBTAINEDFROMPETROLEUMANDISWHOLLYOR
NEARLYDECOLORIZEDISAPURIFIEDMIXTUREOFSEMISOLIDSATURATEDHYDROCARBONS
HAVINGTHEGENERALCHEMICALFORMULA#N(N4HEHYDROCARBONSCONSISTMAINLY
OFBRANCHEDANDUNBRANCHEDCHAINS7HITEPETROLATUMCONTAINSBUTYLATED
HYDROXYTOLUENE"(4ASSTABILIZER
%ACHGRAMOF653)/.CONTAINSMGOFMICONAZOLENITRATE530
MGOFZINCOXIDE530ANDMGOFWHITEPETROLATUM530CONTAININGBUTY
LATEDHYDROXYTOLUENETRIHYDROXYSTEARINAND#HEMODERM®"FRAGRANCE
653)/.ISASMOOTHUNIFORMWHITEOINTMENT
Page 3
653)/.
N
:INC/XIDE7HITE0ETROLATUM
N
4WOADDITIONALSTUDIESPROVIDEDSUPPORTIVEEVIDENCEOFTHECLINICAL
EFFICACYOF653)/.ININFANTSANDTODDLERSWITHDIAPERDERMATITISSOMEOF
WHOMCULTUREDPOSITIVEFORC. albicans(OWEVERCANDIDALINFECTIONWASNOT
DOCUMENTEDINTHECULTUREPOSITIVESUBJECTSASMICROSCOPICTESTINGEG
+/(WASNOTDONE4HEREFORETHEPOSITIVECULTURERESULTSMAYHAVEREFLECTED
COLONIZATIONRATHERTHANINFECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
653)/.ISASMOOTHUNIFORMWHITEOINTMENTSUPPLIEDINANALUMINUM
TUBEASFOLLOWSG.$#
16.2 Storage Conditions
3TOREATCONTROLLEDROOMTEMPERATUREBETWEEN—#AND—#—&AND
—&WITHEXCURSIONSPERMITTEDBETWEEN—#AND—#—&AND—&
+EEPOUTOFREACHOFCHILDREN
Page 4
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling
0ATIENTSUSING653)/.SHOULDBEINFORMEDABOUTTHEFOLLOWINGINFORMATION
s
653)/.ISTOBEUSEDONLYFORDIAPERDERMATITISTHATISCOMPLICATEDBY
DOCUMENTEDCANDIDIASISIEDOCUMENTEDBYMICROSCOPICTESTING
s 653)/.SHOULDNOTBEUSEDASASUBSTITUTEFORFREQUENTDIAPERCHANGES
s 653)/.SHOULDNOTBEUSEDTOPREVENTDIAPERDERMATITIS
s 653)/.SHOULDNOTBEUSEDLONGTERM
s 653)/.SHOULDBEUSEDONLYASDIRECTEDBYTHEHEALTHCAREPROVIDER
s 653)/.ISFOREXTERNALUSEONLY)TISNOTFORORALOPHTHALMICORINTRAV
AGINALUSE
s 'ENTLYCLEANSETHEDIAPERAREAWITHLUKEWARMWATERORAVERYMILDSOAP
ANDPATTHEAREADRYWITHASOFTTOWELBEFOREAPPLYING653)/.
s 'ENTLYAPPLY653)/.TOTHEDIAPERAREAWITHTHEFINGERTIPSAFTEREACH
DIAPERCHANGE$ONOTRUB653)/.INTOTHESKINASTHISMAYCAUSEAD
DITIONALIRRITATION
s 4HOROUGHLYWASHHANDSAFTERAPPLYING653)/.
s 4REATMENTSHOULDBECONTINUEDFORDAYSEVENIFTHEREISIMPROVE
VUSION
is a registered trademark of Stiefel
MENT$ONOTUSE653)/.FORLONGERTHANDAYS)FSYMPTOMSHAVENOT
Laboratories,
Inc.
IMPROVEDBYDAYSEEYOURHEALTHCAREPROVIDER
Manufactured
for:
s 653)/.SHOULDNOTBEUSEDONCHILDRENFORWHOMITISNOTPRESCRIBED
-ANUFACTUREDFOR
0RESTIUM0HARMA)NC
Prestium
Pharma, Inc.
.EWTOWN0!
Newtown, PA 18940
-ANUFACTUREDBY
by
'LAXO3MITH+LINE
GlaxoSmithKline
-ISSISSAUGA/.#ANADA
Mississauga,
-ADEIN#ANADA ON, Canada
Made
in Canada
Ú$ELCOR!SSET#ORPORATIONANAFFILIATEOF0RESTIUM0HARMA)NC
©
2013
Delcor Asset Corporation, an affiliate of Presium
2EVISED/CT63.0),
Pharma, Inc.
Dec 2013
FDA-Approved Patient Labeling
VUSION® (Vu-sion) Ointment
(0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum)
IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.
PATIENT PACKAGE INSERT
2EADTHE0ATIENT)NFORMATIONTHATCOMESWITH653)/.BEFOREYOUUSEITON
YOURCHILD4HISLEAFLETDOESNOTTAKETHEPLACEOFTALKINGTOYOURHEALTHCARE
VUSION®
PROVIDERABOUTYOURCHILDSMEDICALCONDITIONORTREATMENT)FYOUHAVEANY
(0.25% miconazole nitrate USP, 15% zinc oxide USP,
QUESTIONSORIFYOUARENOTSUREABOUTANYOFTHEINFORMATIONON653)/.ASK
and 81.35% white petrolatum USP)
YOURHEALTHCAREPROVIDERORPHARMACIST
How should I use VUSION on my child?
653)/.ISAPPLIEDTOTHESKINONYOURCHILDSDIAPERAREAATEACHDIAPER
CHANGEFORDAYS
!PPLY653)/.FORTHEFULLDAYSEVENIFTHEDIAPERRASHSTARTSTOGOAWAY#ALL
YOURCHILDSHEALTHCAREPROVIDERIFTHEDIAPERRASHGETSWORSEORDOESNOTGO
AWAYWITHDAYSOFTREATMENTWITH653)/.VUSION should not be used for
more than 7 days.
To apply VUSION:
s 'ENTLYCLEANTHESKINONYOURCHILDSDIAPERAREAWITHWARMnot hot WATER9OUMAYALSOUSEAVERYMILDSOAP0ATTHEAREADRYWITHASOFT
TOWEL
s 5SEYOURFINGERTIPSANDGENTLYAPPLYATHINLAYEROF653)/.TOYOUR
CHILDSDIAPERAREAATEACHDIAPERCHANGE$ONOTRUB653)/.INTOYOUR
CHILDSSKIN2UBBINGTHESKINCANCAUSEMOREIRRITATION
s 7ASHYOURHANDSAFTERAPPLYING653)/.ONYOURCHILD
VUSION is for skin use only.
#ALLYOURCHILDSHEALTHCAREPROVIDERORPOISONCONTROLCENTERRIGHTAWAYIFANY
653)/.ISSWALLOWED#ALLYOURCHILDSHEALTHCAREPROVIDERIF653)/.GETS
INTHEEYE
Keep out of reach of children.
What other steps will help diaper rash go away?
s #HECKYOURCHILDSDIAPEROFTEN#HANGETHEDIAPERATTHEFIRSTSIGNOF
WETNESS
s #LEANYOURCHILDSDIAPERAREAAFTEREACHDIAPERCHANGE'ENTLYWIPETHE
DIAPERAREAFROMTHEFRONTTOBACKUSINGWARMnot hot WATER9OUMAY
ALSOUSEAMILDSOAP2INSETHEDIAPERAREAWELL0ATDRYWITHASOFTTOWEL
s +EEPTHEDIAPERAREAOPENTOAIRWHENPOSSIBLE
s %VENIFYOUUSE653)/.diaper rash will not go away if you do not
keep your child’s diaper area clean and dry.
What are the possible side effects of VUSION?
653)/.MAYCAUSEIRRITATION9OUSHOULDCALLYOURCHILDSHEALTHCAREPROVIDER
IFIRRITATIONAPPEARSORIFTHEDIAPERRASHGETSWORSE
How should I store VUSION?
s Keep VUSION out of the reach of children to avoid the risk of
accidental ingestion.
s 3TORE653)/.ATROOMTEMPERATUREBETWEEN—&TO—&—#TO—#
General information about VUSION
-EDICINESARESOMETIMESPRESCRIBEDFORCONDITIONSTHATARENOTMENTIONEDIN
PATIENTINFORMATIONLEAFLETS
$ONOTUSE653)/.FORACONDITIONFORWHICHITWASNOTPRESCRIBED$ONOT
GIVE653)/.TOOTHERCHILDRENORFAMILYMEMBERSEVENIFTHEYHAVETHESAME
SYMPTOMSYOURCHILDHAS)TMAYHARMTHEM
4HISLEAFLETSUMMARIZESTHEMOSTIMPORTANTINFORMATIONABOUT653)/.)F
YOUWOULDLIKEMOREINFORMATIONTALKTOYOURCHILDSHEALTHCAREPROVIDER9OU
CANASKYOURCHILDSHEALTHCAREPROVIDERORPHARMACISTFORINFORMATIONABOUT
653)/.THATISWRITTENFORHEALTHCAREPROFESSIONALS
provider will need to do a special
Ointment
WhatSkin
is VUSION?
For
Use Only
Your healthcare
653)/.ISAPRESCRIPTIONSKINMEDICINEUSEDTOTREATDIAPERRASHTHATALSO
effects
may be
reported
Prestium
Pharma, Inc. at 1-866-897-5002
Read the Patient Information that comes with VUSION test to tell if yourSide
child’s
diaper
rash
also tohas
a yeast
HASAYEASTINFECTIONINCHILDRENWHOAREATLEASTWEEKSOLDANDWHOHAVEA
or theVUSION
FDA at 1-800-FDA-1088.
Ointment
before you use it on your child. This leaflet infection. Do not use
Ointment on your child’s
NORMALIMMUNESYSTEM653)/.CONTAINSMEDICINESTHATWILLHELPTREATTHE
does
not take the place of talking
your
healthcare
What
arehealthcare
the ingredients
in VUSION?
diaper rash unless
your
provider
tells you
YEASTINFECTIONANDTHEDIAPERRASHbut
youto
must
also
change your child’s
Ingredients:
provider
child’s
medical
condition
or diaper.
that there is also Active
a yeast
infection.MICONAZOLENITRATEZINCOXIDEANDWHITEPETROLATUM
diapers veryabout
often soyour
that your
child is
not wearing
a wet or soiled
%VENIFYOUUSE653)/.diaper
will not or
go away
you do
treatment.
If you have any rash
questions
if youif are
notnot keep
Do not use VUSION
Ointment
on anyTRIHYDROXYSTEARINBUTYLATEDHYDROXYLTOLUENE"(4AND
other children.
Inactive
Ingredients:
®
your child’s
and dry.9OUSHOULDUSEWATERORAVERYMILD
#HEMODERM
"FRAGRANCE
sure
aboutdiaper
any ofarea
the clean
information
on VUSION Ointment,
Do not use VUSION
Ointment
on your child’s diaper
CLEANSERTOCLEANYOURCHILDSDIAPERAREA653)/.ISNOTTOBEUSEDTOPREVENT
VUSION
is a registered
of Stiefel
ask your health care provider, or pharmacist.
rash if they are allergic
to anything
in it. See the trademark
end of
4HIS0ATIENT)NFORMATIONLEAFLETHASBEENAPPROVEDBYTHE53&OODAND$RUG
DIAPERRASHORTOBEUSEDFORMORETHANDAYS
Laboratories,
Inc.in VUSION Ointment.
!DMINISTRATION
What is VUSION Ointment?
this leaflet for a list
of ingredients
Your health
care provider
need to do skin
a special
test to tell
if your child’s
for: on my child?
VUSION
Ointment
is a will
prescription
medicine
used
4HE0ATIENT)NFORMATIONLEAFLETWASLASTREVISED/CTOBER
How should I useManufactured
VUSION Ointment
diaper rash also has a yeast infection. Do not use VUSION on your child’s
to
treat
diaper
rash
that
also
has
a
yeast
infection
in
VUSION
Ointment-ANUFACTUREDFOR
is applied to the skin on your child’s
diaper rash unless your health care provider tells you that there is also
a
children
who have a normal immune system. VUSION
diaper area at each diaper change for 7 days.
yeast infection.
Ointment contains medicines that will help treat the
Apply VUSION Ointment for the full 7 days even if
Who should not use VUSION?
yeast
infection and the diaper rash, but you must also the diaper rash starts to go away. Call your child’s
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Page 5
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