PRO-LINK OPTIMUM FOAMING MEDICATED HANDWASH- triclosan liquid
Pro-Link, Inc.

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.

----------

PRO•LINK® OPTIMUM™ Foaming Medicated Handwash

Active ingredient

Triclosan 0.3%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin before and after contact with a person under medical care or treatment
Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly 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

Wet hands
Apply a small amount of product and work into a lather
Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Propylene Glycol, Alcohol, Lauric Acid, Ethanolamine, Disodium Cocoamphodiacetate, Lactic Acid, Isopropyl Alcohol, PEG-4, Polyquaternium-10, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Iodopropynyl Butylcarbamate, Green 3 (CI 42053)

Product Label

PRO-LINK OPTIMUM FOAMING MEDICATED HANDWASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66908-096
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.003 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
LAURIC ACID (UNII: 1160N9NU9U)
MONOETHANOLAMINE (UNII: 5KV86114PT)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
LACTIC ACID (UNII: 33X04XA5AT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66908-096-42	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/30/2004	12/01/2021

Labeler - Pro-Link, Inc. (144650637)

Revised: 11/2018

Document Id: 57032ed5-1ef1-49d9-a84b-8cf4c77e83c5

Set id: 028a9e91-ac71-45df-9ddc-2e47fe410d83

Version: 2

Effective Time: 20181120

Pro-Link, Inc.