Label: SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS- benzalkonium chloride liquid

  • NDC Code(s): 35000-088-11, 35000-088-55, 35000-088-91
  • 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 December 10, 2019

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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, sodium chloride, fragrance, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, PEG-40 hydrogenated castor oil, methylchloroisothiazolinone, methylisothiazolinone, 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 - 1.48 L Bottle Label

    Softsoap®
    brand

    KITCHEN FRESH HANDS®
    ANTIBACTERIAL HAND SOAP

    ODOR NEUTRALIZING

    Citrus
    Extracts

    USE ONLY WITH
    SOFTSOAP®
    ANTIBACTERIAL
    UNIQUE FORMULA

    REFILL

    50 FL OZ
    (1.56 QT) 1.48 L

    9928847

    PRINCIPAL DISPLAY PANEL - 1.48 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-088
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-088-551478 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2019
    2NDC:35000-088-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2016
    3NDC:35000-088-911656 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/19/2016
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-088) , MANUFACTURE(35000-088) , PACK(35000-088) , LABEL(35000-088)
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