Label: WINNING HANDS PREMIUM ANTIBACTERIAL- 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 November 12, 2012

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  • Winning Hands Premium Antibacterial

    ​Active Ingredient

    ​ ​Chloroxylenol 0.5%

  • Winning Hands Premium Antibacterial

    Uses

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

    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.
  • Winning Hands Premium Antibacterial

    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
  • Winning Hands Premium Antibacterial

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Coco Diethanolimide, Cocamidopropyl Betaine, Phenoxyethanol, Sodium Laureth Sulfate, Allantoin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice, Glycerine, FD&C Yellow #5, FD&C Red #40.

  • Winning Hands Premium Antibacterial

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • Winning Hands Premium Antibacterial

    Purpose

    Antibacterial

  • Winning Hands Premium Antibacterial

    KEEP OUT OF REACH OF CHILDREN

  • Winning Hands Premium Antibacterial

    Winning Hands Premium Antibacterial

    SKIN CLEANSER

    Premium Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

    Net Contents: 30.4 fl. oz. (900 mL)

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  • INGREDIENTS AND APPEARANCE
    WINNING HANDS PREMIUM ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-736
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5.0 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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-736-19900 mL in 1 BAG
    2NDC:65601-736-101100 mL in 1 BAG
    3NDC:65601-736-043780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (005050158)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(65601-736)
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