Label: ANTIBACTERIAL- benzethonium chloride liquid

  • NDC Code(s): 68599-5502-1, 68599-5502-2, 68599-5502-3
  • Packager: McKesson
  • 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 March 28, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzethonium Chloride @ 0.13%

  • PURPOSE

    Purpose Antiseptic

  • INDICATIONS & USAGE

    Uses

    For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings
    For external use only.

    Do not use in the eyes. Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

  • 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
    • Apply to hands and wet as needed.
    • Lather vigorously for at least 15 seconds.
    • Wash skin, rinse thoroughly and dry.

  • SPL UNCLASSIFIED SECTION

    Other information - Protect from freezing. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Purified Water, Cocamidopropyl Betaine, Lauramine Oxide, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Yellow 5, Red 4, (may contain Citric Acid, Sodium Hydroxide)

  • QUESTIONS

    General Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5502-1
    McKesson
    Foaming Antibacterial Soap
    Clean Scent with Pump
    Net Contents
    8.5 fl oz
    (251 mL)

    53-23123-8.5

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5502-2
    McKesson
    Foaming Antibacterial Soap
    Clean Scent
    Refill for McKesson Pump and Automatic Foam Dispensers MFR#s 53-FOAM and 53-Foam-Auto
    Net Contents
    1000 mL
    (34 fl oz)

    53-23126-1000 (2)

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5502-3
    McKesson
    Foaming Antibacterial Soap
    Clean Scent with Pump
    Net Contents
    18 fl oz
    (532 mL) 53-23127-18 (2)

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5502-1251 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/29/2017
    2NDC:68599-5502-21000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/29/2017
    3NDC:68599-5502-3532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/29/2017
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-5502)
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