Label: HAND SANITIZER- alcohol liquid

  • 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 December 1, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    in children under 2 months of age

    on open wounds

    When using this product

    keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation occurs. These may be signs of a serious condition.

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Place enough product on hands to cover all surfaces. Rub together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    Store between 15-30C (59-86F)

    Avoid Freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Acrylates Copolymer, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethyl Palmate, Fragrance, Glycerin, Water

  • PRINCIPAL DISPLAY PANEL

    Principle display image

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80981-110
    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)  
    ETHYL PALMATE (UNII: PY7890FR5M)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80981-110-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - Johnny Was (080018288)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evergreen Innovations024394560manufacture(80981-110)
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