Label: MOISTURIZING ANTIBACTERIAL- benzalkonium chloride 0.13% soap

  • NDC Code(s): 55316-952-68, 55316-952-96
  • Packager: DZA Brands
  • 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 December 8, 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, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, sodium chloride, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, sodium sulfate, methylchloroisothiazolinone, methylisothiazolinone, red 40, yellow 5, red 33

  • Questions?

    1-866-322-2439

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Colgate-Palmolive Company, distributor of Softsoap Crisp Clean Antibacterial Hand Soap with Moisturizers.*

    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

    light moisturizing hand soap

    antibacterial

    Compare to Softsoap Crisp Clean Antibacterial*

    Hand Soap with Moisturizers

    56 FL OZ (1.65 L)

    image description

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING ANTIBACTERIAL 
    benzalkonium chloride 0.13% soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-952
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-952-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/06/2015
    2NDC:55316-952-681656 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 (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-952)
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