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Major Thera-Gel Therapeutic Anti-Dandruff

Dosage form: shampoo
Ingredients: Coal Tar 0.5mL in 100mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5259

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Major® Thera-Gel™ Therapeutic
Anti-Dandruff

Drug Facts

Active ingredient

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

Purpose

Anti-dandruff

Use

controls the symptoms 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, cocamidopropyl betaine, cocamide DEA, laureth-4, methylparaben, propylparaben, imidazolidinyl urea, sodium chloride, fragrance, citric acid, tetrasodium EDTA, red 40 (CI 16035), caramel

Questions?

Adverse Drug Event Call: 800-616-2471

Distributed By: Major Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150, 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

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

8.5 FL OZ (251 mL)

05-1439A

MAJOR THERA-GEL THERAPEUTIC   ANTI-DANDRUFF
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5259
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Coal Tar (Coal Tar) Coal Tar0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Laureth Sulfate 
Cocamidopropyl Betaine 
Laureth-4 
Sodium Chloride 
Edetate Sodium 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5259-44251 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H09/01/2007
Labeler - Major Pharmaceuticals (191427277)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIOperations
Garcoa, Inc.103039178MANUFACTURE(0904-5259)

Revised: 08/2012
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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