THEOCHEM TEA TREE HAND AND BODY WASH- tea tree hand and body wash soap
Theochem Laboratories 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.

----------

Tea Tree Hand and Body Wash

Active Ingredient

Triclosan 0.2%

Purpose:

Antimicrobial

Uses:

For hand washing to decrease bacteria on the skin.

Warnings:

For external use only.

When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children.

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

Directions:

For use applications, pump dispenser a few times to prime. Wet hands and dispense a small amount of the foamimg product into palm.

Work soap into a rich, foamy lather. Rinse with water.

Other Information:

Hand washing to decrease bacteria on skin. Recommended for repeated use.

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Tetrasodium Salt of Ehylenediamine Tetraacetic Acid, Glycerine, Propylene Glycol, Aloe Extract, FD&C Blue # 1, FD&C Yellow # 5, Fragrance, 1, 2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one

PRINCIPAL DISPLAY PANEL
TEA TREE HAND AND BODY WASH
NET CONTENTS: 1250 ml

Tea Tree 1250 ml

THEOCHEM TEA TREE HAND AND BODY WASH
tea tree hand and body wash soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68878-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.002 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68878-140-21	1250 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/23/2008

Labeler - Theochem Laboratories Inc (004100038)

Registrant - Theochem Laboratories Inc (004100038)

Name	Address	ID/FEI	Business Operations
Establishment
Teochem Laboratories Inc		004100038	manufacture(68878-140)