MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]

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MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]
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NDC 0904-5259-44
Set ID 1c18fde9-d39b-4339-8f62-3f352d450291
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART358H
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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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 FINALpart358H09/01/2007
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(0904-5259)
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