FIRST MARK ANTIBACTERIAL HAND WASH- triclosan liquid

First Mark by

Drug Labeling and Warnings

First Mark by is a Otc medication manufactured, distributed, or labeled by Performance Food Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Antibacterial Handwashing

Active Ingredient

Triclosan 0.3% w/w

Uses

Handwash to help decrease bacteria on the skin

Warnings

For external use only

in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 yearsof age should be supervised when using thisproduct.

INACTIVE INGREDIENT

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Hydroxysultaine, Disodium Cocamido MIPA-Fulfosuccinate, Glycerin, Fragrance, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin, Yellow 5, Red 33.

Principal display panel and representative label

First Mark

#243632

The Mark of Quality In

Non-Food Essentials

Anti Sept

Antibacterial Hand Soap

DISTRIBUTED BY PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY - RICHMOND, VIRGINIA 23238

MADE IN USA

INGREDIENTS AND APPEARANCE

FIRST MARK  ANTIBACTERIAL HAND WASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51042-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51042-050-65	800 mL in 1 BAG; Type 0: Not a Combination Product	06/25/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2010

Labeler - Performance Food Group (127038714)