Label: PROTEX COMPLETE ANTIBACTERIAL BAR- chloroxylenol soap

  • NDC Code(s): 35000-069-01, 35000-069-03, 35000-069-06
  • 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 November 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Chloroxylenol 0.30%

  • Purpose

    Antibacterial

  • Use

    Helps reduce bacteria that potentially can cause disease

  • 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

    Wet bar with water. Lather and wash skin. Rinse and dry thoroughly.

  • Inactive ingredients

    Sodium Laurate/Linoleate/Oleate/Palmitate, Water, Glycerin, Fragrance, Sodium Chloride, Tetrasodium EDTA, Etidronic Acid, Titanium Dioxide.

  • Questions?

    1-800-443-0602

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 104.8 g Applicator Carton

    NEW
    Eliminates 99.9% of bacteria*

    Protex®
    For the Good Health of your Skin
    COMPLETE

    Antibacterial

    Antibacterial Bar Soap
    NET WT 3.7 OZ (104.8 g)

    PRINCIPAL DISPLAY PANEL - 104.8 g Applicator Carton
  • INGREDIENTS AND APPEARANCE
    PROTEX COMPLETE ANTIBACTERIAL BAR 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURATE (UNII: K146MR5EXO)  
    SODIUM LINOLEATE (UNII: 872C9A1W9I)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-069-011 in 1 CARTON12/01/2021
    1104.8 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:35000-069-033 in 1 CELLO PACK12/01/2021
    21 in 1 CARTON
    2104.8 g in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:35000-069-066 in 1 CELLO PACK12/01/2021
    31 in 1 CARTON
    3104.8 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E12/01/2021
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    HADA International S.A.882405152MANUFACTURE(35000-069)
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