Label: ADVANCED HAND SANITIZER 70 PERCENT- ethyl alcohol gel

  • NDC Code(s): 80269-102-12, 80269-102-18, 80269-102-91
  • Packager: Hansair
  • 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 19, 2021

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  • ACTIVE INGREDIENTS

    Ethyl alcohol 70% V/V

  • PURPOSE

    ANTIMICROBIAL

  • USES

    To help reduce bacteria on the skin.
    For use when soap and water are not available.

  • WARNINGS

    For external use only do not take it internally. Use with caution to people who are allergic to alcohol

    Flammable, Keep away from fire or flame

    Stop use and consult physician if irritation and redness develop and persist for more than 72 hours

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water

  • 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

    Take an appropriate amount (2-3ml) of the product to moisten your hands and rub for 15 seconds until the liquid covers your hands, wait for drying, and do not wash with water.

  • INACTIVE INGREDIENTS

    Aqua/Water/Eau, Glycerin, Propylene Glycol, Carbomer, Propanediol, Aminomethyl Propanol, Citrus Paradisi (Grapefruit) Oil, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Marjana_Advanced Hand Sanitizer_1gal

    01b LBL_Marjana_Advanced Hand Sanitizer_2oz

    01b LBL_Marjana_Advanced Hand Sanitizer_8oz

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER  70 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80269-102
    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)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80269-102-913790 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    2NDC:80269-102-1260 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    3NDC:80269-102-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/19/2021
    Labeler - Hansair (187501200)