Label: SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS CRISP CLEAN LHS- benzalkonium chloride liquid

  • NDC Code(s): 35000-251-11, 35000-251-34, 35000-251-91
  • Packager: Colgate-Palmolive 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 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    helps eliminate bacteria on hands

  • Warnings

    For external use only.

    When using this product, avoid contact with eyes.

    In case of contact, flush with water.

    Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    wash hands and rinse

  • Inactive ingredients

    Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, Fragrance, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Tetrasodium EDTA, Red 40, Yellow 5, Red 33.

  • Questions?

    1-800-255-7552

  • SPL UNCLASSIFIED SECTION

    DIST. BY:
    COLGATE-PALMOLIVE COMPANY, NEW YORK, NY 10022 USA

  • PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label

    NEW
    fragrance

    Softsoap
    BRAND

    ANTIBACTERIAL

    +

    ELIMINATES 99.9%
    OF BACTERIA

    ENRICHED WITH
    MOISTURIZERS

    crisp
    clean

    ANTIBACTERIAL HAND SOAP

    11.25 FL OZ (332 mL)

    PS0029908

    Principal Display Panel - 332 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS CRISP CLEAN LHS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.33 mg  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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    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:35000-251-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/2022
    2NDC:35000-251-911470 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/2022
    3NDC:35000-251-343780 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E10/04/2022
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    VeePak, Inc874763303MANUFACTURE(35000-251)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex015226132ANALYSIS(35000-251) , MANUFACTURE(35000-251) , PACK(35000-251) , LABEL(35000-251)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-251) , MANUFACTURE(35000-251) , PACK(35000-251) , LABEL(35000-251)
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