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Major Thera-Gel Therapeutic (Major Pharmaceuticals)

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SHAMPOO 251 mL in 1 BOTTLE, PLASTIC (0904-5259-44) Label Information

Complete Major Thera-Gel Therapeutic Information

  • SPL UNCLASSIFIED SECTION

    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


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

    NDC 0904-5259-44

    MAJOR®

    Thera-Gelâ„¢
    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

    PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

  • 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 0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth 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
    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. (103039178)
    Establishment
    Name Address ID/FEI Business Operations
    Garcoa, Inc. 103039178 MANUFACTURE(0904-5259)