Label: WINNING HANDS PREMIUM ANTIBACTERIAL- chloroxylenol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 65601-736-04, 65601-736-10, 65601-736-19 - Packager: Betco Corporation, Ltd.
- Category: HUMAN OTC DRUG LABEL
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
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
- Winning Hands Premium Antibacterial
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INGREDIENTS AND APPEARANCE
WINNING HANDS PREMIUM ANTIBACTERIAL
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-736 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 5.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-736-19 900 mL in 1 BAG 2 NDC:65601-736-10 1100 mL in 1 BAG 3 NDC:65601-736-04 3780 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - Betco Corporation, Ltd. (005050158) Registrant - Betco corporation, Ltd. (005050158) Establishment Name Address ID/FEI Business Operations Betco Corpo, Ltd. 005050158 manufacture(65601-736)