Label: PC537 E-2 BRUTE- chloroxylenol soap

  • 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 January 31, 2018

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  • Active ingredient

    Chloroxylenol 2.5% w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

    • skin cleanser and sanitizer
  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
  • Directions

     wet hands  apply liberal quantity to hands  contact time of one minute is recommended  rinse hands thoroughly with potable water.

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Sodium Lauryl Sulfate, Sodium C14-16 Olefin Sulfonate, Glycerin, Propylene Glycol, Cocamide DEA, Glycol Stearate, Sodium Chloride, Citric Acid.

  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label CARROLL® E-2 BRUTE Sanitizing Hand Creaner  Keep out of reach of children CAUTION: See back panel for additional precautions Net Contents: 1 U.S. gallon / 3.78 liters Item # 537

    image description

  • INGREDIENTS AND APPEARANCE
    PC537 E-2 BRUTE 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10685-537
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL25 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10685-537-11208000 mL in 1 DRUM; Type 0: Not a Combination Product10/16/2013
    2NDC:10685-537-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/16/2013
    Labeler - CARROLL COMPANY (007372329)
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