MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF- coal tar shampoo

Major Thera-Gel Therapeutic by

Drug Labeling and Warnings

Major Thera-Gel Therapeutic by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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)

INGREDIENTS AND APPEARANCE

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

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)
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	09/01/2007

Labeler - Major Pharmaceuticals (191427277)

Registrant - Garcoa, Inc. (036464697)

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