Label: HAND SANITIZER- 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 December 17, 2020

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  • Active Ingredient

    Alcohol 70%v/v

  • Purpose

    Antiseptic

  • Uses

    ■ Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available

  • Warnings

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

  • Do not use

    ■ on children less than 2 months of age ■ on open skin wounds

  • When using this product

    keep out of eyes, ears, ears and mouth. In case of eye contact immediately flush eyes thoroughly with water

  • Stop use and ask a doctor

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

  • Keep out of reach of children

    In case of accidentail ingestion, contact a doctor or Poison Control Center immediately.

  • Directions

    ■ Place enough product on hands to cover all surfaces. ■Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    ■ Store between 15º-30ºC (59º-89ºF) ■ Avoid freezing and excessive heat above 40ºC (104ºF) ■ May discolor fabrics or surfaces.

  • Inactive ingredients

    Acrylates/Vinyl Isodecanoate Crosspolymer, Denatonium Benzoate, Glycerin, Polyethylene Glycol, Tert-Butyl Alcohol, Water

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79332-008
    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)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79332-008-283790 mL in 1 BOTTLE, PLASTIC; 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 - Zink Holdings LLC (117561710)
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