Label: VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 January 3, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62 PERCENT
  • PURPOSE

    ANTISEPTIC

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

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

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 1100F (430C).

  • QUESTIONS OR COMMENTS

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200).

  • PACKAGE FRONT AND BACK LABELS

    IMAGE OF VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER 2 FL OZ

  • INGREDIENTS AND APPEARANCE
    VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VANILLA (UNII: Q74T35078H)  
    APPLE (UNII: B423VGH5S9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-265-0259 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/03/2011
    Labeler - HEB (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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