FIRST MARK FOAM ANTIMICROBIAL HAND CLEANER- 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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Drug Facts

Active Ingredient

Triclosan 0.5%

Purpose

Antibacterial Handwashing

Uses

For handwashing to decrease bacteria on skin.

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use and ask doctor if, in rare instances, redness and irritation develop and persists for more than 72 hours.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds, Add water, lather, rinse.

Inactive Ingredients Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium,-7, Aloe Barbadensis Leaf, Tocopheryl Acetate, Disodium Cocamido MIPA Sulfosuccinate, Tetrasodium EDTA, Fragrance, Citric Acid, Polyquaternium-10, DMDM Hydantoin, Yellow 5, Red 33

Principal display panel and representative container

REORDER#

243551

FIRST

MARK

THE MARK OF QUALITY IN NON-FOOD ESSENTIALS

FOAMING

ANTIMICROBIAL

HAND SOAP

33.8 Fl. Oz. (1000 mL)

DISTRIBUTED BY:

PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY

RICHMOND, VA 23238

REPREsentative label

FIRST MARK FOAM ANTIMICROBIAL HAND CLEANER
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51042-689
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
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:51042-689-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/24/2010
2	NDC:51042-689-17	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/24/2010	08/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/24/2010	08/15/2022

Labeler - Performance Food Group (127038714)

Revised: 12/2021

Document Id: ee1295fb-c01b-4eae-b4b0-5b1a57d79acb

Set id: 66899ee8-4024-4e8a-b0f5-993ed0f7e56d

Version: 3

Effective Time: 20211210

Performance Food Group