Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

FRESH LINEN ANTIBACTERIAL FOAMING HAND WASH- triclosan liquid 
SJ Creations, 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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Drug Facts

Active Ingredient

Triclosan 0.2% (Purpose: Antiseptic)

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

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

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

Keep out of the reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

Inactive Ingredients

Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water (aqua), Disodium EDTA, Fragrance (Perfume) Glycerin, Methylchloroisothiazolinone and Methylisothiazolinone, Polysorbate 20, Sodium Laureth Sulfate.

FRESH LINEN ANTIBACTERIAL FOAMING HAND WASH 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-780
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
OXYBENZONE (UNII: 95OOS7VE0Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-780-17	517 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2012	05/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2012	05/15/2014

Labeler - SJ Creations, Inc. (146379495)

Revised: 6/2019

Document Id: 8aaae8eb-bf70-43e0-e053-2995a90add79

34390-5

Set id: 55ddf2db-dc88-46a4-a198-7870d34d1dbb

Version: 2

Effective Time: 20190606