Label: HAND SANITIZER 70 PERCENT- 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 October 19, 2021

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 70% V/V

  • PURPOSE

    ANTISEPTIC

  • USES

    TO DECREASE BACTERIA ON THE SKIN THAT POTENTIALLY CAN CAUSE DISEASE

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

    DO NOT USE IN THE EYES.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR PAIN OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS

    • APPLY A SUFFICIENT AMOUNT OF PRODUCT TO YOUR PALM TO COVER BOTH HANDS.
    • RUB UNTIL DRY.

  • OTHER INFORMATION

    • STORE BELOW 110F (43C)
  • INACTIVE INGREDIENTS

    AQUA, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, HYDROXYETHYLCELLULOSE, CITRUS LIMON PEEL OIL

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand Sani Wipe_70pct EtOH_front

    01b LBL_Hand Sani Wipe_70pct EtOH_back

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER   70 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72580-309(NDC:43219-105)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72580-309-033 mL in 1 POUCH; Type 0: Not a Combination Product08/25/2020
    2NDC:72580-309-011.5 mL in 1 POUCH; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - Formology Lab Inc. (081102403)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emilia Cosmetics Ltd600076624manufacture(72580-309) , relabel(72580-309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Agrippas Industries Ltd.600579170pack(72580-309)
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