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 June 24, 2020

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  • ACTIVE INGREDIENT

    Alcohol (62%)

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    For external use only

    Do not use in or near the eyes

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children

    If swallowed, contact a doctor or Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping

  • INACTIVE INGREDIENT

    Water, Hydrogenated starch, Carbomer, Tetrahydroxypropyl Ethylenediamine, Fragrance

  • PRINCIPAL DISPLAY PANEL

    331 Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ETHYLENEDIAMINE CARBAMATE (UNII: 5823XF90GJ)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-110-018 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2010
    Labeler - Bullet Line, LLC (122539042)
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