NEUTROGENA TGEL THERAPEUTIC STUBBORN ITCH- coal tar shampoo

Neutrogena TGel Therapeutic Stubborn Itch by

Drug Labeling and Warnings

Neutrogena TGel Therapeutic Stubborn Itch 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 0.5% (2% Neutar® Solubilized Coal Tar Extract)

Purpose

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

Use

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis.

Warnings

For external use only.

Do not use

• for prolonged periods without consulting a doctor.
• this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

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

When using this product

• Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.

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.

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 a few minutes.
• Rinse and repeat.

Other information

In rare instances, temporary discoloration of gray, blonde, bleached, or tinted hair may occur.

Store away from direct sunlight.

Inactive ingredients

Water, Sodium Laureth Sulfate, Cocamide MEA, Laureth-4, Polysorbate 20, Fragrance, Polyquaternium-46, Propylene Glycol, Menthol, PEG-55 Propylene Glycol Oleate, Bis-PEG-18 Methyl Ether Dimethyl Silane, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, DMDM Hydantoin, Tetrasodium EDTA, Sodium Chloride, Sodium Hydroxide

Questions?

Call toll-free 877-256-4247 or 215-273-8755 (collect). www.neutrogena.com

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corporation
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Carton

NEUTROGENA®
T/Gel®
therapeutic
shampoo

Stubborn Itch

soothes intense
scalp itch with
cooling menthol

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

#1 DERMATOLOGIST
RECOMMENDED BRAND

Neutrogena®

2% NEUTAR®
(COAL TAR 0.5%)

4.4 FL. OZ. (130 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA TGEL THERAPEUTIC STUBBORN ITCH 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC)	Coal Tar	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Coco Monoethanolamide (UNII: C80684146D)
Laureth-4 (UNII: 6HQ855798J)
Polysorbate 20 (UNII: 7T1F30V5YH)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Sodium (UNII: MP1J8420LU)
DMDM Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-505-04	1 in 1 CARTON	12/01/2008
1		130 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	12/01/2008

Labeler - Johnson & Johnson Consumer Inc. (002347102)