Label: PC529 ULTREX- 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 0.25% 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

    Hand washing in public washrooms, work areas, healthcare facilities,

    ofice buildings, food service facilities, and wherever cleanliness and

    antimicrobial properties are desired.

  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
  • Directions

     apply small amount of product to hands.  hold hands under water and work cleaner into lather.   rinse hands with water and wipe clean.

  • Other information

     store at room temperature

     recommended for use in Wall Mount Dispenser

  • Inactive ingredients:

    Water, Potassium Cocoate, TEA Cocoyl Hydrolyzed Collagen, hydroxyethyl Cellulose, Glycol Distearate, Sodium Laureth Sulfate, Myristyl Alcohol, Cocamidopropyl Betaine, Sodium Chloride, C9-11 Pareth-6, Fragrance, Propylene Glycol, Tetrasodium EDTA, Isopropyl Myristate, FD & C Red #40, D &C Red #33, Methylchloroisothiazolinone (and) Methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL - 800 mL Bag Label CLEAN N FRESH® Ultrex Antimicrobial Hand Soap 800 ml CARROLL® Company Garland, TX 75041

    image description

  • INGREDIENTS AND APPEARANCE
    PC529 ULTREX 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10685-529
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10685-529-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/21/2014
    2NDC:10685-529-17800 mL in 1 BAG; Type 0: Not a Combination Product01/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/21/2014
    Labeler - CARROLL COMPANY (007372329)
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