Label: HAND SANITIZER- benzalkonium chloride 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 2, 2014

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.13%

  • PURPOSE

    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin

  • 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, cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride

  • nonalcohol

    nonalcoholnonalcohol

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-120-018 g in 1 BOTTLE, PLASTIC
    2NDC:19392-120-0330 g in 1 BOTTLE, PLASTIC
    3NDC:19392-120-0450 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/02/2014
    Labeler - Humphreyline (122539042)