Label: WINNING HANDS FOAMING ANTIBACTERIAL- tricolsan 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 December 4, 2012

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  • Winning Hands Foaming Antibacterial

    ​Active Ingredient

    ​ ​Triclosan 0.30%

  • Winning Hands Foaming Antibacterial

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
  • Winning Hands Foaming 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 Foaming Antibacterial

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 0.8 mL of product onto wet palm.
    • Rub hands together to distribute product, then rinse hands with clean.
  • Winning Hands Foaming Antibacterial

    Inactive Ingredients

    ​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

  • Winning Hands Foaming Antibacterial

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

    MDS information:​(800) 891-4965

  • Winning Hands Foaming Antibacterial

    Purpose

    Antibacterial

  • Winning Hands Foaming Antibacterial

    KEEP OUT OF REACH OF CHILDREN

  • Winning Hands Foaming Antibacterial

    Winning Hands Foaming Antibacterial

    75155-00

    Foaming Skin Cleanser with Triclosan

    NET CONTENTS: 55 gallons (U.S./E.U.) 208 L

    75155.jpg

  • INGREDIENTS AND APPEARANCE
    WINNING HANDS FOAMING ANTIBACTERIAL 
    tricolsan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-751
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA Leaf (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-751-541000 mL in 1 BOTTLE, PLASTIC
    2NDC:65601-751-55208000 mL in 1 DRUM
    3NDC:65601-751-043780 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/12/2012
    Labeler - Betco Corporation, Ltd. (005050158)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(65601-751)
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