Drug Facts

Active ingredient

Solubilized Coal Tar Extract 2.5% (Coal Tar, 0.5%)

Purpose

Anti-dandruff

Use

controls the symptom of:

♦: dandruff
♦: seborrheic dermatitis
♦: psoriasis

Warnings

For external use only

Ask a doctor before use if you have a condition which covers a large part of the body

When using this product

♦: do not get into 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.
♦: do not use for prolonged periods without consulting a doctor
♦: do not use with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs unless directed to do so by 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.

Directions

♦: wet hair thoroughly
♦: massage shampoo into the scalp
♦: lather. Leave on hair and scalp for several minutes
♦: rinse and repeat
♦: for best results use at least twice a week or as directed by a doctor

Other information

♦: store away from direct sunlight
♦: in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, tetrasodium EDTA, DMDM hydantoin, caramel, red 40

Questions or comments?

Adverse drug event call: 800-616-2471

Distributed By: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152, USA

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

NDC 0904-5259-44

MAJOR®

Thera-Gel™
THERAPEUTIC
SHAMPOO

ORIGINAL FORMULA

Coal Tar 0.5%

Long Lasting Relief of
Itching and Flaking

Controls the Symptoms of:

Seborrheic Dermatitis
Psoriasis
Dandruff

05-1439A

*Compare to the active ingredient of
Neutrogena® T/Gel® Therapeutic Shampoo

8.5 FL OZ (251 mL)

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5259
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Laureth-4 (UNII: 6HQ855798J)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Sodium (UNII: MP1J8420LU)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-5259-44	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M032	09/01/2007

Labeler - Major Pharmaceuticals (191427277)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(0904-5259)

Major® Thera-Gel™ Therapeutic Anti-Dandruff