Indications and uses
To control the symptoms of dandruff, seborrheic dermatitis, and psoriasis
Tera-Gel
- Manufacturer
- Geritrex LLC
- Effective date
- 2016-01-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:46
Label at a glance#
ProductTera-Gel
Active ingredientCOAL TAR
Label structure9 sections
Dosage and administration
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
Storage and handling
15°-30°C (59°-86°F).
Label contents#
Full prescribing information#
Active Ingredient
Active Ingredient Purpose
0.5% Coal Tar . . . . . . . . . . . . . . . Anti-Dandruff, Anti-Seborrheic
Dermatitis, Anti-Psoriasis
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 SECTION
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 SECTION
15°-30°C (59°-86°F).
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed get prompt medical
attention or contact a poison control center immediately.
Inactive Ingredients:
Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water, DMDM Hydantoin, Fragrance, Methylparaben, Polysorbates 20 & 80, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 309381 | coal tar 0.5 % Medicated Shampoo | PSN | 1 |
| 284305 | Tera Gel 0.5 % Medicated Shampoo | PSN | 1 |
| 284305 | coal tar 5 MG/ML Medicated Shampoo [Tera Gel] | SBD | 1 |
| 309381 | coal tar 5 MG/ML Medicated Shampoo | SCD | 1 |
| 309381 | coal tar 0.5 % Medicated Shampoo | SY | 1 |
| 309381 | crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated Shampoo | SY | 1 |
| 284305 | Tera Gel 0.5 % Medicated Shampoo | SY | 1 |
| 284305 | Tera Gel 5 MG/ML Medicated Shampoo | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54162-250-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-27c1-f424-e053-dadaa90a57ce | Tera-Gel Shampoo |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54162-250-04 | Tera-Gel | 114 mL in 1 BOTTLE, PLASTIC | SHAMPOO | 114 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54162-250-04 | ML - Milliliter | 54162-250 | 97ab7a99-304b-4158-b9ac-674e4dc35cd2 | 1 | 2016-02-04 |
| 54162-250-80 | ML - Milliliter | 54162-250 | f7d093e1-aeb6-497d-af65-c3a7b7b82398 | 1 | 2016-02-04 |
Products#
Every source-derived product name is available through these pages.
- Tera-Gel
- COAL TAR
- WATER
- COCO DIETHANOLAMIDE
- POLYSORBATE 20
- POLYSORBATE 80
- CITRIC ACID MONOHYDRATE
- COCAMIDOPROPYL BETAINE
- DMDM HYDANTOIN
- METHYLPARABEN
- PROPYLPARABEN
- SODIUM CHLORIDE
- SODIUM LAURETH SULFATE
- EDETATE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54162-250 | 54162-250-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| COAL TAR | R533ESO2EC | ACTIB |
| WATER | 059QF0KO0R | IACT |
| COCO DIETHANOLAMIDE | 92005F972D | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM LAURETH SULFATE | BPV390UAP0 | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 159e9ddd-d861-453b-8bf0-c2a0d603fd7c | 6f079fa9-2fa2-4988-ae1b-46b8fd670fac | 2016-01-19 | Warnings | 159e9ddd-d861-453b-8bf0-c2a0d603fd7c 6f079fa9-2fa2-4988-ae1b-46b8fd670fac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.