Label: BLISTEX IVAREST- zinc oxide and diphenhydramine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 12, 2017

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  • PRINCIPAL DISPLAY PANEL - 35 g Tube Carton

    Blistex

    IVAREST®

    PRINCIPAL DISPLAY PANEL - 35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    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)