Label: PROTEX BALANCE ANTIBACTERIAL HAND- benzalkonium chloride liquid

  • NDC Code(s): 35000-675-12, 35000-675-75
  • 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 eye 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

    Apply to hands, wash and rinse. Unique Formula. Refill only with Protex

  • Inactive ingredients

    water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, fragrance, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow No. 5, D&C red No. 33

  • Questions?

    Call toll-free 1-800-443-0602

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    COLGATE-PALMOLIVE COMPANY, Distr.
    Guaynabo, P.R. 00968-1705

  • PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

    Eliminates 99.9% of Bacteria*

    Protex®

    For the Good Health of your Skin
    Daily Protection Against Bacteria

    BALANCE
    • DERMATOLOGIST •
    TESTED

    Antibacterial Liquid Hand Soap

    9904820
    7.5 FL OZ (221 mL)

    Principal Display Panel - 221 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROTEX BALANCE ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-675
    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 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:35000-675-75221 mL in 1 BOTTLE; Type 0: Not a Combination Product08/22/2013
    2NDC:35000-675-123780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/22/2013
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company079342773ANALYSIS(35000-675) , MANUFACTURE(35000-675) , PACK(35000-675) , LABEL(35000-675)
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