Label: ANTIBACTERIAL SANITIZER- ethyl alcohol liquid

  • 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 August 8, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    TO DECREASE THE BACTERIA ON THE SKIN

  • WARNINGS

    FOR EXTERNAL USE ON THE HANDS ONLY. IN CASE OF ACCIDENTAL INGESTION SEEK MEDICAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

    STOP USE AND ASK DOCTOR

    IF SKIN IRRITATION DEVELOPS

    KEEP OUT OF THE REACH OF CHILDREN

    FOR CHILDREN UNDER 6, USE ONLY WITH ADULT SUPERVISION. NOT RECOMMENDED FOR USE ON INFANTS.

  • DIRECTIONS

    SPRAY A SMALL AMOUNT ONTO HANDS AND BRISKLY RUB HANDS TOGETHER UNTIL DRY

  • OTHER INFORMATION

    FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.

  • INACTIVE INGREDIENTS

    WATER, PROPYLENE GLYCOL, GLYCERIN, FRAGRANCE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

  • LABEL COPY

    image of the label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  SANITIZER
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-235
    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)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-235-017.4 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/08/2011
    Labeler - H E B (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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