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 July 19, 2012

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  • ACTIVE INGREDIENT

    Alcohol (62%)

  • PURPOSE

    Antimicrobial

  • 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

    Keep out of eyes

    Keep out of reach of children

    Flammable-keep away from open flame

  • DOSAGE & ADMINISTRATION

    Recommended for repeated use

  • INACTIVE INGREDIENT

    Water, Hydrogenated starch, Carbomer, Tetrahydroxypropyl Ethylenediamine, Fragrance

  • PRINCIPAL DISPLAY PANEL

    gel one ounce art

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-210
    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)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-210-0215 mL in 1 BOTTLE, PLASTIC
    2NDC:19392-210-0330 mL in 1 BOTTLE, PLASTIC
    3NDC:19392-210-0444 mL in 1 BOTTLE, PLASTIC
    4NDC:19392-210-0560 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2010
    Labeler - Humphreyline (122539042)