Label: ANTIBACTERIAL- benzalkonium chloride liquid

  • NDC Code(s): 50157-004-64
  • Packager: Brands International Corporation
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 25, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Uses for handwashing or decrease bacteria to the skin

  • WARNINGS

    Warnings For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using this product

    • do not get it into eyes. If contact occurs, rinse eye thoroughly with water
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse
  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

  • PRINCIPAL DISPLAY PANEL

    Antibacterial Liquid Soap

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-004
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-004-641900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2016
    Labeler - Brands International Corporation (243748238)
    Registrant - Sante Manufacturing Inc (242048747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-004)
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