WINNING HANDS PREMIUM ANTIBACTERIAL- chloroxylenol soap 
Betco Corporation, Ltd.

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.

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Winning Hands Premium Antibacterial

Winning Hands Premium Antibacterial

​Active Ingredient

​Chloroxylenol 0.5%

Winning Hands Premium Antibacterial

Uses

Winning Hands Premium Antibacterial

Warnings

Winning Hands Premium Antibacterial

Directions

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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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)

Revised: 11/2012
Document Id: f89eece0-4cb8-4e75-ad8a-cbbee0bb29df
Set id: c6606ee0-f332-421f-bf2f-81b4bd0a869d
Version: 1
Effective Time: 20121112
 
Betco Corporation, Ltd.