Supreme (Chloroxylenol) Soap [Brookmeade Hardware & Supply Co.] -

SUPREME (CHLOROXYLENOL) SOAP [BROOKMEADE HARDWARE & SUPPLY CO.]
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NDC	68304-141-04
Set ID	f69a27af-ff83-49e4-bd7b-8e46be7deb7c
Category	HUMAN OTC DRUG LABEL
Packager	Brookmeade Hardware & Supply Co.
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68304-141-04	3780 mL in 1 JUG

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

Labeler - Brookmeade Hardware & Supply Co. (034842716)

Registrant - Betco corporation, Ltd. (005050158)

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

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