Label: HAND WASH- benzalkonium chloride soap

  • NDC Code(s): 71897-022-08, 71897-022-45, 71897-022-86
  • Packager: Veritiv Operating Company
  • 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 September 19, 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 only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly 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 4, yellow 5

  • SPL UNCLASSIFIED SECTION

    Distributed

    Veritiv Operating Company

    Atlanta,  GA 30328

    reliablebrand.com

    8944 837 4848

  • principal panel display

    Stock No / Articulo N V03285

    Original scent

    Helps kill harmful germ

    Gentle and mild

    Helps smooth and soften skin

    With moisturizers

    Reliable

    GOLD ANTIBACTERIAL

    Hand Soap

    1 US gal

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71897-022
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    glycerin (UNII: PDC6A3C0OX)  
    DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71897-022-081000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    2NDC:71897-022-863790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    3NDC:71897-022-451150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/23/2018
    Labeler - Veritiv Operating Company (006989982)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(71897-022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(71897-022)
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