TORK PREMIUM ANTIBACTERIAL- triclosan soap
SCA Tissue North America

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 0.3%

Purpose

Antiseptic Handwash

Uses

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

For external use only.

Ask a doctor before use if you have

Deep wounds, animal bites or serious burns.

When using this product

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

Stop use and ask a doctor if

irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a Poison Control Center.

Inactive ingredients

Water, Sodium Lauryl Sulfate, Sodium C14-16 Sulfonate, Cocamidopropyl Betaine, Cocamide DEA, Glycerin, Disodium R-MEA Sulfosuccinate, Ammonium Chloride, Fragrance, Methylchloroisothiazolinone and Methylisothazolinone, Citric Acid, FD&C Yellow #5, FD&C Red #4.

Package/Label Principal Display Panel

TORK®

Premium

Soap

Liquid Antibacterial

34 oz.

(1000 ml)

TORK PREMIUM ANTIBACTERIAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49351-400
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49351-400-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2009	12/31/2016

Labeler - SCA Tissue North America (005694349)

Revised: 1/2016

Document Id: 2a547937-f005-585c-e054-00144ff8d46c

Set id: eaa40298-74e9-4b4b-a2dc-2875005d2ade

Version: 2

Effective Time: 20160127

SCA Tissue North America