BLISTEX IVAREST- zinc oxide and diphenhydramine hydrochloride cream 
Blistex Inc.

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Blistex Ivarest® Crema

PRINCIPAL DISPLAY PANEL - 35 g Tube Carton

Blistex

IVAREST®

PRINCIPAL DISPLAY PANEL - 35 g Tube Carton
BLISTEX IVAREST 
zinc oxide and diphenhydramine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
BENTONITE (UNII: A3N5ZCN45C)  
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CASTOR OIL (UNII: D5340Y2I9G)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9014-135 g in 1 TUBE; Type 0: Not a Combination Product01/09/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY01/09/2015
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9014)

Revised: 5/2017
Document Id: a6b6d4f6-9a6d-458f-b2ef-1a16cebdcd6e
Set id: 12f880e4-9f9e-4461-b0c2-884ed82272a9
Version: 1
Effective Time: 20170512
 
Blistex Inc.