Label: CRANBERRY CAKE- antibacterial hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 4, 2015

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  • CRANBERRY CAKE ANTIBACTERIAL HAND SANITIZER

    ACTIVE INGREDIENT: ETHYL ALCOHOL 62% PURPOSE ANTISEPTIC

    ANTISEPTIC

    USES: TO DECREASE BACTERIA ON THE SKIN AND CLEAN HANDS. RECOMMENDED FOR REPEATED USE

    WARNING: FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    DO NOT GET INTO EYES. IF CONTACT OCCURS,RINSE THROUGHLY WITH WATER.

    DISCONTINUE USE IF IRRITATION OR REDNESS DEVELOP. IF IRRITATION PERSISTS FOR MORE THEN 72 HOURS, CONSULT A DOCTOR.

    SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT.

  • DOSAGE & ADMINISTRATION

    OTHER INFORMATIONMAY DISCOLOR CERTAIN FEBRICS OR SURFACES.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER, PISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHEROL ACETATE, SUNFLOWER (HELIANTHUS ANNUUS) SEED EXTRACT, MAY CONTAIN: FD&C BLUE NO. 1(CI 42090), FD&C RED NO. 40(CI 16035), FD&C YELLOW NO. 5 (CI 19140)

  • CRANBERRY CAKE ANTIBACTERIAL HAND SANITIZER

    image description
  • INGREDIENTS AND APPEARANCE
    CRANBERRY CAKE 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-112-0129 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2015
    Labeler - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-112)
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