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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 653)/.ISNOTFORTREATMENTOFALLCASESOFDIAPERRASH653)/.ISONLYFOR change your child’s diapers very often so that your DIAPERRASHTHATALSOHASAYEASTINFECTION-OSTCASESOFDIAPERRASHDONOT 0RESTIUM0HARMA)NC healthcare provider if the diaper rash gets worse or Pharma, Inc. with VUSION child is not wearing a wet or soiled diaper. Even if you NEEDTHEYEASTMEDICINETHATISIN653)/.BECAUSEMOSTCASESOFDIAPERRASH .EWTOWN0! does not go awayPrestium with 7 days of treatment DONOTALSOHAVEAYEASTINFECTION Newtown, PAshould 18940 not be used for use VUSION Ointment, diaper rash will not go away Ointment. VUSION Ointment -ANUFACTUREDBY ifDoyou do not keep child’s diaper areafamily cleanmember. and not use VUSION onyour any other children or other 'LAXO3MITH+LINE more than 7 days.by GlaxoSmithKline dry. You should use water or a very mild cleanser to -ISSISSAUGA/.#ANADA apply VUSION Ointment: Do not use VUSION on your child’s diaper rash if they are allergic to To anyMississauga, -ADEIN#ANADA ON, Canada clean your child’s diaper area. VUSION Ointment is not thing in it.3EETHEENDOFTHISLEAFLETFORALISTOFINGREDIENTSIN653)/. O Gently, clean the skin on your child’s diaper area with used to prevent diaper rash or to be used for more than Made Canada warm (not hot) Ú$ELCOR!SSET#ORPORATIONANAFFILIATEOF0RESTIUM0HARMA)NC water.inYou may also use a very mild 7$ONOTUSEONINFANTSLESSTHANWEEKSOFAGE days. © 2013 Delcor Asset Corporation, an affiliate of Presium soap. Pat the area dry with a soft towel. 2EVISED/CT63.0), $ONOTUSEININFANTSORCHILDRENWHODONOTHAVEANORMALIMMUNESYSTEM Who should not use VUSION Ointment? Pharma, O Use your fingertips andInc. gently apply a thin layer of VUSION Ointment is not for treatment of all cases of Page 5 6 VUSION Ointment to your child’s diaper area Page at each diaper rash. VUSION Ointment is only for diaper rash diaper change.Dec Do 2013 not rub VUSION Ointment into that also has a yeast infection. Most cases of diaper your child’s skin. Rubbing the skin can cause more rash do not need the yeast medicine that is in VUSION irritation.