Label: SOFTSOAP AB SENSITIVE ROSE WATER AND ALOE LHS- benzalkonium chloride liquid

  • NDC Code(s): 35000-256-11
  • 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 December 2, 2022

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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, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA.

  • Questions?

    1-800-255-7552

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 333 ml Bottle Label

    NEW

    Softsoap
    BRAND

    ANTIBACTERIAL

    sensitive

    HYPOALLERGENIC & DYE FREE

    ELIMINATES 99.9%
    OF BACTERIA*

    rosewater &
    aloe scent

    ANTIBACTERIAL HAND SOAP

    11.25 FL OZ (333 ml)

    PS0041963

    PRINCIPAL DISPLAY PANEL - 333 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP AB SENSITIVE ROSE WATER AND ALOE LHS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-256
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-256-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E12/02/2022
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-256) , MANUFACTURE(35000-256) , PACK(35000-256) , LABEL(35000-256)
    Establishment
    NameAddressID/FEIBusiness Operations
    VeePak, Inc874763303MANUFACTURE(35000-256)
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