Label: HAND SANITIZER 70 PERCENT- ethyl alcohol solution

  • 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 January 17, 2022

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  • Active ingredient

    Ethyl Alcohol 70%

  • PURPOSE

    ANTIBACTERIAL

  • FUNCTION:

    70% Alcohol Hand Sanitizers, kill 99.9% of the bacteria on hands with 2.5 ml of solution for 15 seconds after application.

  • Warnings

    FOR EXTERNAL USE ONLY - HANDS

    KEEP AWAY FROM HEAT, FIRE OR FLAME.

    WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH WITH THOROUGHLY WATER. AVOID CONTACT WITH BROKEN SKIN AND AVOID SWALLOW.

    STOP USE AND ASK A DOCTOR: IF IRRITATION OR REDNESS DEVELOPS OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

  • 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 AMOUNT OF SANITIZER IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS
    • RUB HANDS TOGETHER BRISKLY UNTIL DRY
    • NO RINSING REQUIRED
    • FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION
    • NOT RECOMMENDED FOR INFANTS
  • Inactive ingredients

    WATER, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL

  • OTHER INFORMATION:

    • DO NOT STORE ABOVE 105 (DEGREES FAHRENHEIT)
    • MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES
    • HARMFUL TO WOOD FINISHES AND PLASTICS
  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER   70 PERCENT
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77397-101
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77397-101-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    2NDC:77397-101-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    3NDC:77397-101-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
    4NDC:77397-101-14236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
    5NDC:77397-101-15118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/06/2020
    Labeler - AmmMm, Inc. (808060680)
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