Label: SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS FRESH CITRUS- benzalkonium chloride liquid

  • NDC Code(s): 35000-087-11, 35000-087-26, 35000-087-31, 35000-087-55, view more
    35000-087-75, 35000-087-91
  • 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, lauramidopropyldimethylamine oxide/myristamidopropylamine oxide, cocamide mea, sodium chloride, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, citrus nobilis (mandarin orange) oil, camellia sinensis (green tea) leaf extract, zingiber officinalis (ginger root) oil, FD&C yellow No. 5, FD&C blue No. 1

  • Questions?

    1-800-255-7552

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 1.65 L Bottle Label

    UNIQUE
    FORMULA

    USE
    ONLY WITH
    SOFTSOAP®
    ANTIBACTERIAL

    Softsoap®
    brand

    ANTIBACTERIAL
    HAND SOAP WITH MOISTURIZERS

    GENTLY CLEANS & PROTECTS

    Fresh
    Citrus

    REFILL

    56 FL OZ (1.75 QT) 1.65 L

    96040

    Principal Display Panel - 1.65 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS FRESH CITRUS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-087
    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)  
    MANDARIN OIL (UNII: NJO720F72R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-087-911478 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2018
    2NDC:35000-087-75221 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    3NDC:35000-087-26162 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    4NDC:35000-087-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    5NDC:35000-087-31946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    6NDC:35000-087-551650 mL in 1 BOTTLE; Type 0: Not a Combination Product01/19/2013
    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(35000-087) , MANUFACTURE(35000-087) , PACK(35000-087) , LABEL(35000-087)
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