Label: ANTIBACTERIAL HAND WASH- benzalkonium chloride 0.13% 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 January 17, 2022

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands

  • When using this product

    • avoid contact with the eyes.  If contact occurs, rinse eyes with water
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

  • SPL UNCLASSIFIED SECTION

    Part #0662137

    Distributed by Fastenal Company and its susidiaries

    Winona, MN 55987

    Made in the USA with US and foreign components

    Distributed exclusively by Fastenal

    488.003/488AD

  • principal display panel

    Clean Choice Moisturizing Antibacterial Hand Soap

    Gentle enough for everyday use

    128 FL OZ (1 GAL) 3.78 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WASH 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72024-488
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.313 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    myristamidopropylamine oxide (UNII: 3HSF539C9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
    PEG-150 distearate (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72024-488-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2018
    Labeler - Fastenal (042653634)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72024-488)
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