Label: SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY FUSION- benzalkonium chloride liquid

  • NDC Code(s): 35000-081-11, 35000-081-55, 35000-081-75, 35000-081-91
  • 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

If you are a consumer or patient please visit this version.

  • 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, prunus persica (peach) juice, fragaria ananassa (strawberry) fruit juice, rubus idaeus (raspberry) juice, fructose, methylchloroisothiazolinone, methylisothiazolinone, prunus amygdalus dulcis (sweet almond) seed extract, red 33, blue 1

  • Questions?

    1-800-255-7552

  • SPL UNCLASSIFIED SECTION

    DIST. BY: COLGATE PALMOLIVE COMPANY, NEW YORK, NY 10022 USA

  • PRINCIPAL DISPLAY PANEL - 1478 mL Bottle Label

    Softsoap®
    brand

    ANTIBACTERIAL
    HAND SOAP WITH MOISTURIZERS

    GENTLY CLEANS & PROTECTS

    White Tea &
    Berry Fusion

    USE ONLY WITH
    SOFTSOAP®
    ANTIBACTERIAL
    UNIQUE FORMULA

    PRINCIPAL DISPLAY PANEL - 1478 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY FUSION 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-081
    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)  
    PEACH JUICE (UNII: K37IH01KN1)  
    STRAWBERRY JUICE (UNII: U8NS58UGW0)  
    RASPBERRY JUICE (UNII: 427AYI9PDE)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ALMOND (UNII: 3Z252A2K9G)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUE (Light blue) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-081-911478 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
    2NDC:35000-081-75221 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2015
    3NDC:35000-081-551650 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2015
    4NDC:35000-081-11332 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E05/20/2015
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-081) , MANUFACTURE(35000-081) , PACK(35000-081) , LABEL(35000-081)