Label: HAND SANITIZER- ethyl alcohol 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 February 3, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTIBACTERIAL

  • USES:

    TO DECREASE 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.

    IF SKIN IRRITATION DEVELOPS,

    DISCONTINUE USE AND CONTACT A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS:

    PUT A SMALL AMOUNT IN YOUR PALM AND BRISKLY RUB HANDS TOGETHER UNTIL DRY.

  • OTHER INFORMATION

    FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, ALUMINA, ISOPROPYL MYRISTATE,  TITANIUM DIOXIDE, BUTYROSPERMUM PARKII (SHEA BUTTER) EXRACT, TOCOPHERYL ACETATE, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF HAND SANITIZER

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-238
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHEANUT OIL (UNII: O88E196QRF)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-238-0374 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2011
    Labeler - HEB (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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