FDA.reportPublic FDA data

Major ® Thera-Gel™ Therapeutic Anti-Dandruff

Manufacturer
CVS Health | Garcoa, Inc. | Sigan America, LLC
Effective date
2024-05-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:30

Label at a glance#

ProductCVS Health Vitamin A and D Skin Protectant
Active ingredientLanolin, Petrolatum
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
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN6
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD6
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY6
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-399-01CVS Health Vitamin A and DSkin Protectant454 g in 1 JAROINTMENT4546

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-39951316-399-01

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
Lanolin7EV65EAW6HACTIB
Petrolatum4T6H12BN9UACTIB
Cod Liver OilBBL281NWFGIACT
Soybean Lecithin1DI56QDM62IACT
Microcrystalline WaxXOF597Q3KYIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT

Source Document#

Source XML

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
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
ndc (package): 51316-399-01
ndc (product): 51316-399
ndc11 (package): 51316039901
spl id: 55c9a6e3-d4a6-43e0-9781-37813384a45b
spl set id: fe3ccabb-9644-4091-9dca-ffd96a43ecaf

Reported adverse events (FAERS/openFDA)#

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