Label: SUPREME- 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 19, 2013

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  • Supreme

    ​Active Ingredient

    Chloroxylenol 0.375%

  • Supreme

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
  • Supreme

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Supreme

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto wet palm.
    • Lather and rinse hands with clean water
  • Supreme

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

  • Supreme

    Purpose

    Antibacterial

  • Supreme

    KEEP OUT OF REACH OF CHILDREN

  • Supreme

    Supreme

    Antiseptic Hand Cleaner

    Pearlized Antibacterial Skin Cleanser with PCMX

    BROOKMEADE HARDWARE & SUPPLY CO., Nashville, Tenn. 37210

    Brookmeade 141.jpg

  • INGREDIENTS AND APPEARANCE
    SUPREME 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68304-141
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68304-141-043780 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Brookmeade Hardware & Supply Co. (034842716)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(68304-141) , pack(68304-141) , label(68304-141)
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