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

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Major® Thera-Gel™ Therapeutic
Anti-Dandruff

Drug Facts

Active ingredient

Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)

Purpose

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

Use

controls the symptom of:

Warnings

For external use only.

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.
  • do not use for prolonged periods without consulting a doctor.
  • do not use this product with other forms of psoriasis therapy such as ultraviolet 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 (1-800-222-1222) right away.

Directions

Other information

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, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

Questions or comments?

1-866-567-8600

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:

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5259
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5259-44251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM03205/18/2010
Labeler - Major Pharmaceuticals (191427277)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan America, LLC964976968MANUFACTURE(0904-5259)

Revised: 5/2024
Document Id: 1794ad62-efcb-4dcc-a664-33d465bfaa6d
Set id: 1c18fde9-d39b-4339-8f62-3f352d450291
Version: 5
Effective Time: 20240528
 
Major Pharmaceuticals