NEUTROGENA T/GEL THERAPEUTIC EXTRA STRENGTH- coal tar shampoo

Neutrogena T/Gel Therapeutic by

Drug Labeling and Warnings

Neutrogena T/Gel Therapeutic by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Coal Tar 1.0%

Purpose

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Use

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

Warnings

For external use only

Ask a doctor before use if you have a condition that covers a large area of the body.

Ask a doctor or pharmacist before use if you are using this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

When using this product

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• Use caution when exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
• Do not use for prolonged periods without consulting a doctor

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

*WARNING

This product contains chemicals known to the State of California to cause cancer.

Directions

For best results, use at least twice a week or as directed by a doctor.

• Wet hair thoroughly.
• Massage shampoo into your scalp.
• Lather, leaving on your hair and scalp for several minutes.
• Rinse and repeat.

Inactive ingredients

Water
Sodium Laureth Sulfate
Polysorbate-20
Laureth-4
Cocamidopropyl Betaine
Cocamide MEA
Bishydroxyethyl Dihydroxypropyl Stearammonium Chloride
PEG-120 Methyl Glucose Dioleate
Tetrasodium EDTA
Citric Acid
DMDM Hydantoin
Fragrance

Questions or comments?

Call 1-877-256-4247 (USA only). For more information go to: www.neutrogena.com

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corporation Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

NEUTROGENA®
T/GEL®
Therapeutic shampoo

Extra Strength

controls redness,
intense itching and
flaking of severe
scalp conditions

• Starts working after just one use
• dandruff, psoriasis, seborrheic dermatitis

#1 DERMATOLOGIST
RECOMMENDED BRAND

Neutrogena®
4% NEUTAR®
(Coal tar 1.0%)

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA T/GEL THERAPEUTIC   EXTRA STRENGTH
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-945
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC)	Coal Tar	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
Polysorbate 20 (UNII: 7T1F30V5YH)
Laureth-4 (UNII: 6HQ855798J)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Coco Monoethanolamide (UNII: C80684146D)
PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Edetate Sodium (UNII: MP1J8420LU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
DMDM Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-945-01	12 in 1 TRAY	03/14/2012
1		29 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 10812-945-06	1 in 1 CARTON	03/14/2012
2		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	03/14/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)