WINNING HANDS PREMIUM ANTIBACTERIAL- chloroxylenol soap

Winning Hands Premium Antibacterial by

Drug Labeling and Warnings

Winning Hands Premium Antibacterial by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd., Betco corporation, Ltd., Betco Corpo, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

WINNING HANDS PREMIUM ANTIBACTERIAL 
chloroxylenol soap

Product 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)