Denorex Severe Flakes
- Manufacturer
- Neoteric Cosmetics, Inc.
- Effective date
- 2025-10-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:30:07
Label at a glance#
ProductDenorex Severe Flakes Medicated Anti Dandruff
Active ingredientZINC PYRITHIONE
Label structure10 sections
Contacts and useful links#
Websitewww.denorex.com
www.denorex.com
www.denorex.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Pyrithione zinc 2%
OTC - PURPOSE SECTION
Purposes
Anti-dandruff, anti-seborrheic dermatitis
INDICATIONS & USAGE SECTION
Uses
Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.
• scalp irritation and itching • flaking • scaling
WARNINGS SECTION
Warnings
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.
OTC - WHEN USING SECTION
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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 right away.
DOSAGE & ADMINISTRATION SECTION
Directions
• shake well. • wet hair, apply shampoo and work into lather. • rinse thoroughly. • for best results, use at least twice a week or as directed by a doctor. • do not use on children under 2 years of age, except as directed by a doctor.
Other information
Store at 68-77°F (20-25°C)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aqua/Water/Eau, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Hydroxysultaine, Cocamidopropyl Betain, Glycol Distearate, Menthol, Cocamide MIPA, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Magnesium Aluminum Silicate, Chlorphenesin, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Isopropanolamine, Sodium Polynaphthalenesulfonate, Xanthan Gum, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Phenoxyethanol, Sodium Hydroxide, Citric Acid, Parfum/Fragrance, Citronellol, Coumarin, Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Linalool, Linalyl Acetate, Terpineol
OTC - QUESTIONS SECTION
Questions? Call 1-888-398-1382
email info@denorex.com or visit www.denorex.com
SPL UNCLASSIFIED SECTION
ADVANCED RELIEF
Denorex®
SEVERE FLAKES
MEDICATED ANTI-DANDRUFF
SHAMPOO + CONDITIONER
DISTRIBUTED BY NEOTERIC COSMETICS, INC.
NEW YORK, NY 10003 / MADE IN CANADA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NEW! 2X FLAKE FIGHTING POWER**
ADVANCED RELIEF
Denorex®
SEVERE FLAKES
MEDICATED
ANTI-DANDRUFF
SHAMPOO + CONDITIONER
PYRITHIONE ZINC 2% / DANDRUFF + SEBORRHEIC DERMATITIS
INSTANT FLAKE CONTROL
CONTROLS & RELIEVES:
√ SEVERE FLAKES
√ SCALING
√ ITCHING
√ IRRITATION
associated with dandruff + seborrheic dermatitis
2% PYRITHIONE ZINC
10 FL. OZ. (296 ml)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62673-176-10 | Denorex Severe FlakesMedicated Anti Dandruff | 296 mL in 1 BOTTLE | SHAMPOO | 296 | 1 | |
| 62673-176-10 | Denorex Severe FlakesMedicated Anti Dandruff | 1 in 1 CARTON | SHAMPOO | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Denorex Severe Flakes Medicated Anti Dandruff
- Pyrithione Zinc
- COCAMIDOPROPYL BETAINE
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- XANTHAN GUM
- MAGNESIUM CHLORIDE
- METHYLISOTHIAZOLINONE
- HEXYL CINNAMAL
- PHENOXYETHANOL
- CITRONELLOL
- GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE
- WATER
- COCAMIDOPROPYL HYDROXYSULTAINE
- FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)
- MAGNESIUM NITRATE
- HYDROXYCITRONELLAL
- LINALOOL
- LINALYL ACETATE
- ZINC PYRITHIONE
- MAGNESIUM ALUMINUM SILICATE
- CHLORPHENESIN
- SODIUM C14-16 OLEFIN SULFONATE
- MENTHOL
- SODIUM CHLORIDE
- METHYLCHLOROISOTHIAZOLINONE
- CITRIC ACID
- GLYCOL DISTEARATE
- COCAMIDE MIPA
- GLYCERIN
- ISOPROPANOLAMINE
- SODIUM HYDROXIDE
- LIMONENE, (+)-
- TERPINEOL
- COUMARIN
- GERANIOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62673-176 | 62673-176-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Denorex Severe Flakes Medicated Anti Dandruff | PYRITHIONE ZINC | Neoteric Cosmetics, Inc. | 41ad0d3a-0704-44c9-e063-6394a90ad40d | 2025-10-21 | Warnings | 62673-176-10 62673-176 62673017610 41ad0d3a-0705-44c9-e063-6394a90ad40d 41ad0d3a-0704-44c9-e063-6394a90ad40d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.