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  5. Label Information: Major Thera-gel Therapeutic Anti-dandruff

FDA Label for Major Thera-gel Therapeutic Anti-dandruff

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 251 ML BOTTLE LABEL

Major Thera-gel Therapeutic Anti-dandruff Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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


Otc - Ask Doctor



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.


Otc - Keep Out Of Reach Of Children



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


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:

* Please review the disclaimer below.