Label: CONTROL- 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 February 7, 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, office 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

  • Inactive ingredients:

    Water, Potassium Cocoate, TEA-Cocoyl Hydrolyzed Collagen, Hydroxyethyl Cellulose, Glycol Distearate, Sodium Laureth Sulfate, Myristyl Alcohol, Cocoamidopropyl Betaine, Sodium Chloride, C9-11 Pareth-6, Fragrance, Propylene Glycol, Tetrasodium EDTA, Isopropyl Myristate, Methylchloroisothiazolinone (and) Methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label SSS® triple S CONTROL Antimicrobial Hand Soap Jabón Antibacterial de Manos Premium CAUTION: MAY CAUSE EYE IRRITATION. KEEP OUT OF REACH OF CHILDREN. See back panel for further precautions Net Contents: 1 U.S. gallon / 3.78 liters  Manufactured for:  SSS® triple S Billerica, MA 01862

    image description

  • INGREDIENTS AND APPEARANCE
    CONTROL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59110-517
    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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59110-517-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/23/2014
    Labeler - Standardized Sanitation Systems (001968296)
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