FDA.reportPublic FDA data

Thera-Gel

Manufacturer
Major Pharmaceuticals | Garcoa, Inc. | Sigan America, LLC
Effective date
2024-05-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:26:03

Label at a glance#

ProductThera-Gel
Active ingredientCoal Tar
Label structure11 sections

Dosage and administration

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

Storage and handling

store away from direct sunlight in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Use

INDICATIONS & USAGE SECTION

controls the symptom of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store away from direct sunlight
  • in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

Distributed By: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152, USA

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309381coal tar 0.5 % Medicated ShampooPSN7
309381coal tar 5 MG/ML Medicated ShampooSCD7
309381coal tar 0.5 % Medicated ShampooSY7
309381crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated ShampooSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5259-44Thera-Gel251 mL in 1 BOTTLE, PLASTICSHAMPOO2517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5259-44ML - Milliliter0904-5259d98cc74c-1c8d-4a0f-80f8-ffaf22ce5e7e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Coal TarACTIVE INGREDIENTR533ESO2EC1
Coal TarACTIVE MOIETYR533ESO2EC1
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KX1
Edetate SodiumINACTIVE INGREDIENTMP1J8420LU1
Laureth-4INACTIVE INGREDIENT6HQ855798J1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP01
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-52590904-5259-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Coal TarR533ESO2ECACTIB
Water059QF0KO0RIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Laureth-46HQ855798JIACT
Sodium Chloride451W47IQ8XIACT
Edetate SodiumMP1J8420LUIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-05-28monthly-update2026-06-03 17:40:24

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route
8 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii+route
8 equally ranked IID candidates
Sodium Laureth SulfateSODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JLOTION / TOPICAL1.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JCREAM / TOPICAL1.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JCREAM / TOPICAL1.1 %w/wExact identifier — unii+route
8 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JSOLUTION / TOPICAL5.22 %w/vExact identifier — unii+route
8 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JSOLUTION / TOPICAL5.22 %w/vExact identifier — unii+route
8 equally ranked IID candidates
Laureth-4LAURETH-46HQ855798JLOTION / TOPICAL1.3 %w/wExact identifier — unii+route
8 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium Laureth SulfateSODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera-GelCOAL TARMajor Pharmaceuticals1c18fde9-d39b-4339-8f62-3f352d4502912024-05-28WarningsExact identifier
ndc (package): 0904-5259-44
ndc (product): 0904-5259
ndc11 (package): 00904525944
spl id: 0ee62461-8b30-435e-8069-8947df75f89a
spl set id: 1c18fde9-d39b-4339-8f62-3f352d450291

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.