Active Ingredient
Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)
Thera-gel Shampoo
FDA Label NDC 0904-5259
10 label sections · Submitted to the FDA by Major Pharmaceuticals · 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 active ingredient, purpose, use, warnings, when using this product, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Use
controls the symptom of:
- dandruff
- seborrheic dermatitis
- psoriasis
Warnings
For external use only.
When Using This Product
- avoid contact with the 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 this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
Directions
- for best results use at least twice a week or as directed by a doctor
- wet hair thoroughly
- massage shampoo into the scalp
- lather, leave on hair and scalp for several minutes.
- rinse and repeat
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, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.
Questions Or Comments?
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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)
* Please review the disclaimer below.
