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

  • NDC Code(s): 35000-086-11, 35000-086-20, 35000-086-26, 35000-086-31, view more
    35000-086-34, 35000-086-55, 35000-086-73, 35000-086-75, 35000-086-80, 35000-086-91
  • 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, sodium chloride, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, 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 - 1.47 L Bottle Label

    Softsoap®
    brand

    ANTIBACTERIAL
    HAND SOAP WITH MOISTURIZERS

    GENTLY CLEANS & PROTECTS

    Crisp
    Clean

    USE ONLY WITH
    SOFTSOAP®
    ANTIBACTERIAL

    UNIQUE FORMULA

    REFILL

    50 FL OZ
    (1.56 QT) 1.47 L

    9928895

    PRINCIPAL DISPLAY PANEL - 1.47 L Bottle Label
  • PRINCIPAL DISPLAY PANEL - 3.78 liter Bottle Label

    PROFESSIONAL PRODUCTS

    COLGATE-PALMOLIVE COMPANY

    UNIQUE
    FORMULA

    Use only with
    Softsoap® ANTIBACTERIAL

    Softsoap®
    brand

    ANTIBACTERIAL
    HAND SOAP
    with light moisturizers
    eliminates 99.9% of bacteria

    MEETS HEALTHCARE HANDWASH STANDARDS,
    GENTLE ON HANDS*

    Crisp
    Clean

    Ideal for commercial use
    in foodservice, office
    supply, health care,
    education and lodging

    REFILL
    1 Gallon (3.78 liters)

    9887070

    Principal Display Panel - 3.78 liter Bottle Label
  • PRINCIPAL DISPLAY PANEL - 591 ml Bottle Label

    Softsoap®
    brand

    Antibacterial
    Eliminates 99.9% of Bacteria*

    HAND SOAP
    REFILL

    USE ONLY WITH
    SOFTSOAP®
    ANTIBACTERIAL

    Crisp Clean

    Hand Soap

    20 FL OZ (591 ml)

    9943737

    Principal Display Panel - 591 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS CRISP CLEAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-086
    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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-086-911478 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
    2NDC:35000-086-75221 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    3NDC:35000-086-26162 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    4NDC:35000-086-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    5NDC:35000-086-31946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    6NDC:35000-086-551650 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    7NDC:35000-086-343780 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    8NDC:35000-086-801 in 1 CARTON01/19/201312/31/2018
    8800 mL in 1 BAG; Type 0: Not a Combination Product
    9NDC:35000-086-731890 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    10NDC:35000-086-20591 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/19/2013
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-086) , MANUFACTURE(35000-086) , PACK(35000-086) , LABEL(35000-086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Veepak, Inc.874763303MANUFACTURE(35000-086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex015226132ANALYSIS(35000-086) , MANUFACTURE(35000-086) , PACK(35000-086) , LABEL(35000-086)
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