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NDC 00904-5259-44 Major Thera-Gel Therapeutic 5 mg/mL Details
Major Thera-Gel Therapeutic 5 mg/mL
Major Thera-Gel Therapeutic is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is COAL TAR.
Product Information
| NDC | 00904-5259 |
|---|---|
| Product ID | 0904-5259_b1367f00-0447-485c-8504-3dabe0bc95f1 |
| Associated GPIs | 90520010004505 |
| GCN Sequence Number | 005977 |
| GCN Sequence Number Description | coal tar SHAMPOO 0.5 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 23611 |
| HICL Sequence Number | 002557 |
| HICL Sequence Number Description | COAL TAR |
| Brand/Generic | Generic |
| Proprietary Name | Major Thera-Gel Therapeutic |
| Proprietary Name Suffix | Anti-Dandruff |
| Non-Proprietary Name | Coal Tar |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SHAMPOO |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | COAL TAR |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part358H |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-5259-44 (00904525944)
| NDC Package Code | 0904-5259-44 |
|---|---|
| Billing NDC | 00904525944 |
| Package | 251 mL in 1 BOTTLE, PLASTIC (0904-5259-44) |
| Marketing Start Date | 2010-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.00872 |
| Pricing Unit | ML |
| Effective Date | 2023-11-22 |
| NDC Description | THERA-GEL 0.5% SHAMPOO |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 1c18fde9-d39b-4339-8f62-3f352d450291 Details
Warnings
For external use only
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.
Directions
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label
INGREDIENTS AND APPEARANCE
| MAJOR THERA-GEL THERAPEUTIC
ANTI-DANDRUFF
coal tar shampoo |
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| Labeler - Major Pharmaceuticals (191427277) |
| Registrant - Garcoa, Inc. (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sigan Industries INC. | 255106239 | MANUFACTURE(0904-5259) | |
Revised: 1/2022
Document Id: b1367f00-0447-485c-8504-3dabe0bc95f1
Set id: 1c18fde9-d39b-4339-8f62-3f352d450291
Version: 3
Effective Time: 20220113