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Dosageform:ointment
Ingredients:CAMPHOR(SYNTHETIC)52mgin1mL,EUCALYPTUSOIL12mgin1mL,MENTHOL28mgin
1mL
Labeler:CVS
NDCCode:59779717
Disclaimer:MostOTCdrugsarenotreviewedandapprovedbyFDA,howevertheymaybemarketediftheycomplywithapplicableregulationsand
policies.FDAhasnotevaluatedwhetherthisproductcomplies.
drugfacts
ActiveingredientPurpose
Camphor5.2%.............................CoughSuppressantandtopicalanalgesic
Eucalyptusoil1.2%......................CoughSuppressant
Menthol2.8%................................CoughSuppressantandtopicalanalgesic
ActiveingredientPurpose
Camphor5.2%.............................CoughSuppressantandtopicalanalgesic
Eucalyptusoil1.2%......................CoughSuppressant
Menthol2.8%................................CoughSuppressantandtopicalanalgesic
Uses
onchestandthroat,temporarilyrelievescoughduetocommoncold
Onmusclesandjoints,temporarilyrelievesminorachesandpains
Keepoutofreachofchildren.Ifswallowed,get
medicalhelporcontactaPoisonControlCenterrightaway.
Usestemporarilyrelievescoughduetominorthroat
andbronchialirritationassociatedwithacold.
Warnings
Forexternaluseonlyavoidcontactwiththeeyes.
Donotuse
bymouthwithtightbandagesinnostrilsonwoundsordamagedskin
Askadoctorbeforeuseifyouhave
coughthatoccurswithtoomuchphlegm(mucus)
persistentorchroniccoughsuchasoccurswithsmoking,asthmaoremphysema.
Whenusingthisproduct,donot
heatmicrowaveaddtohotwateroranycontainer
whereheatingwater.Maycausesplatteringand
resultinburns.
Stopuseandaskadoctorif
muscleachesandpainspersistformorethan7daysorcomeback
coughlastsformorethan7days,comesbackoroccurswithfever,rashor
persistentheadache.Thesecouldbesignsofaseriouscondition.
Ifpregnantorbreastfeeding,askaprofessionalbeforeuse.
Keepoutofreachofchildren.Ifswallowed,get
medicalhelporcontactaPoisonControlCenterrightaway.
Directions
SeeImportantwarningsunder"Whenusingthis
product"
Adultsandchildren2yearsandolder:
rubathicklayeronchestandthroatorrubonsoreachingmuscles
coverwithawarm,dryclothifdesired
keepclothinglooseaboutthroat/chesttohelpvaporsreachthenose/mouth
repeatuptothreetimesper24hoursorasdirectedbyadoctor.
Childrenunder2yearsofage"askadoctor.
OtherInformation
storeatroomtemperature
InactiveIngredients
Carbomer954,cedarleafoil,cetylalcohol,
cetylpalmitate,cyclomethiconecopolyol,
dimethiconecopolyol,dimethicone,ETDA,
glycerin,imidazolidinylurea,isopropylpalmitate,
methylparaben,nutmegoil,PEG100stearate,
propylparaben,purifiedwater,sodiumhydroxide,
stearicacid,thymol,titaniumdioxide,
turpentineoil
CAMPHOR,EUCALYPTUSOILANDMENTHOL
camphor,eucalyptusoilandmentholointment
ProductInformation
ProductType
HUMANOTCDRUG
ItemCode(Source)
NDC:59779717
RouteofAdministration
RESPIRATORY(INHALATION)
DEASchedule
ActiveIngredient/ActiveMoiety
IngredientName
BasisofStrength
Strength
CAMPHOR(SYNTHETIC)(CAMPHOR
(SYNTHETIC))
CAMPHOR(SYNTHETIC)
52mgin1mL
EUCALYPTUSOIL(EUCALYPTUSOIL)
EUCALYPTUSOIL
12mgin1mL
MENTHOL(MENTHOL)
MENTHOL
28mgin1mL
InactiveIngredients
IngredientName
Strength
WATER
CARBOMER934
CETYLALCOHOL
CEDARLEAFOIL
CETYLPALMITATE
CYCLOMETHICONE5
DIMETHICONE
GLYCERIN
DIAZOLIDINYLUREA
ISOPROPYLPALMITATE
METHYLPARABEN
NUTMEGOIL
POLYOXYL100STEARATE
PROPYLPARABEN
SODIUMHYDROXIDE
STEARICACID
STEARYLALCOHOL
THYMOL
TITANIUMDIOXIDE
TURPENTINE
Packaging
#
ItemCode
PackageDescription
NDC:5977971701
1BOTTLE,PLASTIC(BOTTLE)in1
CARTON
237mLin1BOTTLE,PLASTIC
MarketingInformation
MarketingCategory
ApplicationNumberorMonograph
Citation
MarketingStartDate
OTCmonographnotfinal
part348
05/19/2009
MarketingEndDate
LabelerCVS(062312574)
RegistrantPharmaPac,LLC(140807475)
Establishment
Name
PharmaPac,LLC
Address
ID/FEI
Operations
140807475
manufacture
Revised:02/2011
CVS
Disclaimer:Everyefforthasbeenmadetoensurethattheinformationprovidedhereisaccurate,uptodateandcomplete,butnoguaranteeismadeto
thateffect.Druginformationcontainedhereinmaybetimesensitive.Thisinformationhasbeencompiledforusebyhealthcarepractitionersand
consumersintheUnitedStates.Theabsenceofawarningforagivendrugorcombinationthereofinnowayshouldbeconstruedtoindicatethatthe
drugorcombinationissafe,effectiveorappropriateforanygivenpatient.Ifyouhavequestionsaboutthesubstancesyouaretaking,checkwithyour
doctor,nurseorpharmacist.