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 21, 2012

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  • ACTIVE INGREDIENT

    Ethanol (71%)

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    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.

  • INACTIVE INGREDIENT

    Purified water, isopropanol, glycerin, glycerol monolaurate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Recommended for repeated use

  • PRINCIPAL DISPLAY PANEL

    pen spray art


  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL710 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isopropyl alcohol (UNII: ND2M416302)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl laurate (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-100-017 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/11/2012
    Labeler - Humphreyline (122539042)