PROFORMANCE SERIES ANTIBACTERIAL- triclosan liquid

ProFormance Series Antibacterial by

Drug Labeling and Warnings

ProFormance Series Antibacterial by is a Otc medication manufactured, distributed, or labeled by Pro-Link, Inc., Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Triclosan, 0.30%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses

For hand washing to reduce bacteria on the skin

WARNINGS

Warnings

For external use only

When using this product avoid contact with the eyes.

In case of eye contact, flush with water.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Enter section text here

DOSAGE & ADMINISTRATION

Directions

Apply foaming cleanser to dry hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

INACTIVE INGREDIENT

Inactive ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, PPG-24-Glycereth-24, Cocamidopropyl Betaine, Tetrasodium EDTA, 2-Bromo-2-nitropropane-1,3-diol, Fragrance, Citric Acid, Green 5 (CI 61570), Yellow 5 (CI 19140).

PRINCIPAL DISPLAY PANEL

ProFormance Series

Antibacterial Foam Soap

Pro-Link

MA1000

Distributed exclusively by Pro-Link, Inc.

1 Liter

33.8 Fluid Ounces

INGREDIENTS AND APPEARANCE

PROFORMANCE SERIES ANTIBACTERIAL  
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66908-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.30 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 66908-053-27	1000 mL in 1 BOTTLE, PLASTIC
2	NDC: 66908-053-12	1200 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	01/01/2011

Labeler - Pro-Link, Inc. (144650637)

Registrant - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture