Label: FOAMING HAND- 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 February 23, 2023

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  • Drug Facts

  • Active Ingredient

    0.13% Benalkonium chloride

    Purpose

    Antibacterial

  • Use

    helps eliminate bacteria on hands

  • Warning

    For external use only

    When using this product

    do not use in near the eyes. In case of contact, rinse eyes thoroughly with water.

    Keep out of reach of children,

    except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wash hands and rinse

  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Coconut Oil Diethanolamide, Sodium Lauryl Sulfate, Phenoxyethanol, Parfume, Sodium Benzoate, Citric Acid

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82110-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82110-001-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/27/2021
    Labeler - SHIBY INC (855021984)
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