TRICLOSAN- triclosan liquid
GOJO Industries, 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.

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Active ingredient

Triclosan 0.3%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin
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), Coconut Acid, Sodium Sulfate, Oleic Acid, Ethanolamine, Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Hydrolyzed Vegetable Protein, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone

Product Label

TRICLOSAN
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-415
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)
COCONUT ACID (UNII: 40U37V505D)
SODIUM SULFATE (UNII: 0YPR65R21J)
OLEIC ACID (UNII: 2UMI9U37CP)
MONOETHANOLAMINE (UNII: 5KV86114PT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCO-BETAINE (UNII: 03DH2IZ3FY)
Propylene Glycol (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-415-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/10/2010
2	NDC:21749-415-20	2000 mL in 1 BOX; Type 0: Not a Combination Product	03/10/2010
3	NDC:21749-415-16	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/10/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/10/2010	12/01/2021

Labeler - GOJO Industries, Inc. (004162038)

Registrant - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-415)

Revised: 10/2016

Document Id: d494364a-723f-48fc-b6c5-d8395444935c

Set id: 754b9722-3bb6-4f6f-9253-814a54b701aa

Version: 4

Effective Time: 20161014

GOJO Industries, Inc.