Label: INSTANT HAND SANITIZER - alcohol gel

  • NDC Code(s): 41520-225-15
  • Packager: AMERICAN SALES COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

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  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    • IRRITATION OR RASH DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DIRECTIONS

    • APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
    • CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
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  • OTHER INFORMATION

    DO NOT STORE ABOVE 110OC (43 OC). MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

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  • PURPOSE

    ANTISEPTIC

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  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE.

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  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-225
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    PROPYLENE GLYCOL  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    AMINOMETHYLPROPANOL  
    CARBOMER 934  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-225-15 443 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 02/01/2013
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-225)
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