FDA.reportPublic FDA data

Denorex Therapeutic

Manufacturer
Neoteric Cosmetics, Inc. | Pharma Nobis, LLC
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:45:18

Label at a glance#

ProductDenorex Therapeutic
Active ingredientCOAL TAR, MENTHOL
Label structure12 sections

Indications and uses

relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis extra relief of itching due to dandruff

Dosage and administration

shake well  apply to wet hair gently massage into hair and scalp to work up a lather rinse thoroughly and repeat for best results, use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Coal tar solution 9.0% v/v (equivalent to 1.8% coal tar)

Purpose:

OTC - PURPOSE SECTION

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

Purpose:

OTC - PURPOSE SECTION

Controls scalp itch

Uses:

INDICATIONS & USAGE SECTION

  • relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
  • extra relief of itching due to dandruff

Warnings:

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • for prolonged periods without consulting a doctor
  • this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

condition covers a large area of the body.

When using this product:

OTC - WHEN USING SECTION

  • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
  • use caution in exposing skin to sunlight after applying. It may increase your tendency to sunburn for up to 24 hours after application.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • shake well 
  • apply to wet hair
  • gently massage into hair and scalp to work up a lather
  • rinse thoroughly and repeat
  • for best results, use at least twice a week or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol 7.3%, avocado oil, chloroxylenol, citric acid, dimethicone copolyol, FD&C red #40, fragrance, glycol distearate, hydroxypropyl methylcellulose, lauramide DEA, panthenol (provitamin B5), PEG-30 lanolin, quaternium-80, ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate, vitamin E acetate, water

WARNING:

WARNINGS SECTION

This product contains a chemical known to the State of California to cause cancer.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Den Threa Lbl 032021.jpg.jpgDen Threa Lbl 032021.jpg.jpgDen Thera IFC 032021.jpg.jpgDen Thera IFC 032021.jpg.jpgDen0174.jpgDen0174.jpgTHERAPEUTIC

Denorex

1.8 % Coal Tar; 1.5 % Menthol

Maximum Itch Relief

DANDRUFF

SHAMPOO +

CONDITIONER

10 FL OZ (296mL)

THERAPEUTIC Denorex 1.8 % Coal Tar; 1.5 % Menthol Maximum Itch Relief DANDRUFF SHAMPOO + CONDITIONER 10 FL OZ (296 mL)THERAPEUTIC Denorex 1.8 % Coal Tar; 1.5 % Menthol Maximum Itch Relief DANDRUFF SHAMPOO + CONDITIONER 10 FL OZ (296 mL)

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-17462673-174-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AVOCADO OIL6VNO72PFC1IACT
CHLOROXYLENOL0F32U78V2QIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCOL DISTEARATE13W7MDN21WIACT
HYPROMELLOSES3NXW29V3WOIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
PANTHENOLWV9CM0O67ZIACT
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATEV176GWC2SRIACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
COAL TARR533ESO2ECACTIB
MENTHOLL7T10EIP3AACTIB

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
23e8cabe-1882-3187-e063-6394a90ab6ea603bb8c1-c492-d859-e053-2a91aa0aeb332024-10-07WarningsExact identifier
spl id: 23e8cabe-1882-3187-e063-6394a90ab6ea
spl set id: 603bb8c1-c492-d859-e053-2a91aa0aeb33

Reported adverse events (FAERS/openFDA)#

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