Label: HAND WASH- benzalkonium chloride soap

  • NDC Code(s): 55316-403-68, 55316-403-96
  • Packager: DZA Brands, LLC
  • 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 June 15, 2023

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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, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, PEG-120 methyl glucose dioleate, fragrance, sodium sulfate, sodium chloride, citric acid, tetrasodium EDTA, phenoxyethanol, methylisothiazolinone, yellow 5, red 4

  • Questions?

    1-800-213-904

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: DZA BRANDS, LLC

    2110 Executive Drive

    Salisbury, NC 28147

    For product questions or concerns,

    contact us at 1-866-322-2439

    Please include UPC number and code from package

  • Principal display panel

    healthy accents

    antibacterial hand soap

    56 FL OZ (1.65 L)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-403
    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)  
    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)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-403-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/06/2015
    2NDC:55316-403-681656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/06/2015
    Labeler - DZA Brands, LLC (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-403)
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