Thera-gel Shampoo
FDA Label NDC 0904-5259

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Thera-gel (NDC 0904-5259). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - ask doctor, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

  • 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)

    Principal Display Panel (251 mL Bottle Label)

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