SUPREME- chloroxylenol soap

Supreme by

Drug Labeling and Warnings

Supreme by is a Otc medication manufactured, distributed, or labeled by Brookmeade Hardware & Supply Co., Betco corporation, Ltd., Betco Corpo, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Supreme

​Active Ingredient

Chloroxylenol 0.375%

Supreme

Uses

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

Supreme

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.

Supreme

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

Supreme

Inactive Ingredients

​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

Supreme

Purpose

Antibacterial

Supreme

KEEP OUT OF REACH OF CHILDREN

Supreme

Supreme

Antiseptic Hand Cleaner

Pearlized Antibacterial Skin Cleanser with PCMX

BROOKMEADE HARDWARE & SUPPLY CO., Nashville, Tenn. 37210

INGREDIENTS AND APPEARANCE

SUPREME 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68304-141
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 LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
GLYCERIN (UNII: PDC6A3C0OX)
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: 68304-141-04	3780 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/12/2012

Labeler - Brookmeade Hardware & Supply Co. (034842716)

Registrant - Betco corporation, Ltd. (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corpo, Ltd.		005050158	manufacture(68304-141) , pack(68304-141) , label(68304-141)