FDA.reportPublic FDA data

Denorex Severe Itch

Manufacturer
Neoteric Cosmetics, Inc.
Effective date
2024-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:21

Label at a glance#

ProductDenorex Severe Itch
Active ingredientCOAL TAR
Label structure11 sections

Indications and uses

Reduces and helps prevent recurrence of these symptoms of dandruff: scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff

Dosage and administration

for best results, use at least twice a week or as directed by a doctor shake well before use apply to wet hair massage into scalp, leave lather on for several minutes rinse thoroughly and repeat for maximum relief

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Coal Tar 1.8%
(from Coal Tar Topical Solution, USP 20%)

Purpose:

OTC - PURPOSE SECTION

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

Uses:

INDICATIONS & USAGE SECTION

Reduces and helps prevent recurrence of these symptoms of dandruff:

  • scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff

Warnings:

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a condition covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if 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

  • for best results, use at least twice a week or as directed by a doctor
  • shake well before use
  • apply to wet hair
  • massage into scalp, leave lather on for several minutes
  • rinse thoroughly and repeat for maximum relief

Other information

SPL UNCLASSIFIED SECTION

Store at 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40

Questions?

OTC - QUESTIONS SECTION

Call 1-888-398-1382

email info@denorex.com or visit www.denorex.com

WARNING:

SPL UNCLASSIFIED SECTION

This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADVANCED RELIEF

Denorex®
SEVERE ITCH

MEDICATED

ANTI-DANDRUFF

SHAMPOO + CONDITIONER


1.8 % Coal Tar / DANDRUFF,

SEBORRHEIC DERMATITIS + PSORIASIS

INSTANT SOOTHING RELIEF

CONTROLS & RELIEVES:

SEVERE ITCHING

SCALP DISCOMFORT

INFLAMMATION

FLAKING & SCALING

associated with dandruff, seborrheic dermatitis + psoriasis

1.8% COAL TAR

10 FL OZ (296 mL)

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-175-10Denorex Severe Itch296 mL in 1 BOTTLESHAMPOO2961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62673-175DENOREX SEVERE ITCH (COAL TAR) SHAMPOO [NEOTERIC COSMETICS, INC.]1Current NDC, 1 package rows20250523_213ccbc4-2f52-58b6-e063-6294a90ae248.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-17562673-175-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHANOLAMINE SULFATEMV1V89M17OIACT
PEG/PPG-4/12 DIMETHICONEJAN3585W85IACT
COCO DIETHANOLAMIDE92005F972DIACT
ALCOHOL3K9958V90MIACT
AVOCADO OIL6VNO72PFC1IACT
CHLOROXYLENOL0F32U78V2QIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCOL DISTEARATE13W7MDN21WIACT
HYPROMELLOSES3NXW29V3WOIACT
PANTHENOLWV9CM0O67ZIACT
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATEV176GWC2SRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
COAL TARR533ESO2ECACTIB
SUNFLOWER OIL3W1JG795YIIACT
PEG-30 LANOLINJSB8U68Q2UIACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
QUATERNIUM-80C29NCR5LBEIACT
MENTHOLL7T10EIP3AIACT

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
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
ndc (package): 62673-175-10
ndc (product): 62673-175
ndc11 (package): 62673017510
spl id: 213cb08a-41af-72f5-e063-6294a90a41f2
spl set id: 213ccbc4-2f52-58b6-e063-6294a90ae248

Reported adverse events (FAERS/openFDA)#

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