ANTIBACTERIAL SKIN CLEANSER- chloroxylenol soap

Antibacterial Skin Cleanser by

Drug Labeling and Warnings

Antibacterial Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd., Betco corporation, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chloroxylenol 0.375%

Uses

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

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.
• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• ​Read the entire label before using this product.
• ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
• Rinse with clean water.

Inactive Ingredients

​Water, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

Winning Hands Antibacterial

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

©2017 Betco Corporation
400 Van Camp Road Bowling Green, Ohio 43402
Made In U.S.A. All Rights Reserved.

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL SKIN CLEANSER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-708-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2016
2	NDC: 65601-708-19	900 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
3	NDC: 65601-708-41	2000 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
4	NDC: 65601-708-55	207900 mL in 1 DRUM; Type 0: Not a Combination Product	02/01/2016
5	NDC: 65601-708-10	1100 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
6	NDC: 65601-708-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012

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. (024492831)

Registrant - Betco corporation, Ltd. (024492831)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		024492831	manufacture(65601-708) , pack(65601-708) , label(65601-708)