Active Ingredient
Active Ingredient Purpose
0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic
Dermatitis, Anti-Psoriasis
Tera-gel
FDA Label NDC 54162-250
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Tera-gel (NDC 54162-250). 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, uses, directions, dosage & administration, warnings, storage and handling, otc - keep out of reach of children, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
To control the symptoms of dandruff,
seborrheic dermatitis, and psoriasis
Directions
For best results, use at least twice a week or as directed by a physician.
• Wet hair and scalp thoroughly.
• Massage shampoo into scalp.
• Leave lather on hair and scalp for several minutes.
• Rinse and repeat
Dosage & Administration
For best results, use at least twice a week or as directed by a physician.
Warnings
FOR EXTERNAL USE ONLY
Consult a physician before use if you have a condition that
covers a large area of the body. Consult a physician or pharmacist
before using if you intend to use this product with other forms of
psoriasis therapy such as ultraviolet radiation or prescription drugs.
When using this product:
• Avoid contact with eyes. If contact occurs, rinse eyes
thoroughly with water.
• If improvement does not occur, or condition worsens after
regular use, as directed, consult a physician.
• Use caution when exposing skin to sunlight after using this
product. It may increase the tendency to sunburn for up
to 24 hours after using this product.
• Do not use for prolonged periods without consulting a doctor.
If condition worsens or does not improve after regular use of
this product as directed, stop use and consult a physician.
Storage And Handling
15°-30°C (59°-86°F).
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get prompt medical
attention or contact a poison control center immediately.
Inactive Ingredients:
Black Shade R, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, FD&C Red #33, Fragrance, Methylparaben, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.
* Please review the disclaimer below.
