Label: SOFTSOAP ANTIBACTERIAL CLEAN AND PROTECT COOL SPLASH- benzalkonium chloride liquid

  • NDC Code(s): 35000-096-11
  • 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 November 4, 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

    Wet hands and apply soap. Lather front and back, between your fingers, and under your nails. Scrub for at least 20 seconds, rinse then dry.

  • Inactive ingredients

    Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, 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

    Softsoap®
    brand

    Antibacterial
    Clean & Protect

    ELIMINATES 99.9% OF BACTERIA
    THAT POTENTIALLY CAUSE DISEASE*

    ENRICHED WITH MOISTURIZERS

    Cool Splash

    Hand Soap
    With Moisturizers

    11.25 FL OZ
    (332 mL)

    0013086

    PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL CLEAN AND PROTECT COOL SPLASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-096
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-096-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product11/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E11/23/2020
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-096) , MANUFACTURE(35000-096) , PACK(35000-096) , LABEL(35000-096)
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