Label: ANTIBACTERIAL GOLD- benzalkonium chloride soap

  • 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 23, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Use

    For washing to decrease bacteria on the skin

  • Warnings

    For external use only

    • Avoid contact with eyes. In case of eye contact, flush with water.
    • Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet bar with water
    • Lather vigorously and wash skin
    • Rinse and dry thoroghly
  • Inactive Ingredient

    butylated hydroxytoluene, cocamidopropyl betaine, edetate sodium, etidronate tetrasodium, fragrance, sodium chloride, sodium cocyl isethionate, sodium laureth-5 sulfate, sodium palm kernelate, sodium palmate, stearic acid, titanium dioxide, water

  • Package label

    carton

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL GOLD 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-6 METHYL ETHER (UNII: WXH089JZ5E)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0117-33 in 1 CELLO PACK07/10/2020
    1100 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2020
    Labeler - Kareway Product, Inc. (121840057)
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