FULLER ANTIBACTERIAL HAND- triclosan liquid
The Fuller Brush Company

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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Fuller ANTIBACTERIAL LIQUID HAND SOAP

Active Ingredients

Triclosan 0.5%

Purpose

Handsoap

Use

Handwash to help reduce bacteria which can potentially cause disease.

Warnings

For external use only.

When using this product

avoid contact with eyes

Stop use and ask a doctor

if irritation and redness develop or condition persists for more than 72 hours.

Keep out of reach of children

Directions

Wet hands and apply small amount of product. Scrub thoroughly, rinse and dry.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamide DEA, Cocamidopropyl Betaine, Sodium Chloride, Disodium EDTA, Fragrance, Diazolidinyl Urea, Citric Acid

THE FULLER BRUSH COMPANY Great Bend, KS 67530

Questions or Comments? 1-800-821-7067 Made in U.S.A. 26/0509

Fuller ANTIBACTERIAL LIQUID HAND SOAP 16oz/473ml (11535-112-03)

FULLER ANTIBACTERIAL HAND
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11535-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11535-112-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2012	12/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2012	12/14/2016

Labeler - The Fuller Brush Company (079097729)

Revised: 12/2016

Document Id: 439eca07-5887-1058-e054-00144ff8d46c

Set id: 5c9f8a3c-99d5-4fc8-bb6a-72540826e40f

Version: 4

Effective Time: 20161214

The Fuller Brush Company