FIRST MARK ANTIBACTERIAL HAND WASH- triclosan liquid
Performance Food Group

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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

representative label

FIRST MARK ANTIBACTERIAL HAND WASH
triclosan liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51042-050-65	800 mL in 1 BAG; Type 0: Not a Combination Product	06/25/2010	10/13/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/25/2010	10/13/2022

Labeler - Performance Food Group (127038714)

Revised: 3/2022

Document Id: 952b5d75-5bcd-4826-9592-2b97b30553b3

Set id: 1d41d685-cbc5-4029-b86c-bdde07986f15

Version: 3

Effective Time: 20220323

Performance Food Group