Label: SOFTSOAP ANTIBACTERIAL SPARKLING PEAR- benzalkonium chloride liquid

  • NDC Code(s): 35000-102-11
  • 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 April 14, 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, Sodium Chloride, Cocamide MEA, Fragrance, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

  • 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

    Softsoap
    BRAND

    ANTIBACTERIAL
    +

    gentle clean

    LEAVES SKIN FEELING SOFT

    ELIMINATES 99.9%*
    OF BACTERIA*

    sparkling
    pear

    ANTIBACTERIAL HAND SOAP
    WITH MOISTURIZERS

    11.25 FL OZ (332 mL)

    PS0024434

    Principal Display Panel - 332 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL SPARKLING PEAR 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-102
    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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-102-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E11/16/2020
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-102) , MANUFACTURE(35000-102) , PACK(35000-102) , LABEL(35000-102)
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