Denorex Severe Flakes Medicated Anti-dandruff Shampoo + Conditioner (2% Pyrithione Zinc)

Denorex Severe Flakes Medicated Anti-dandruff Shampoo + Conditioner (2% Pyrithione Zinc)
SPL v1
SPL
SPL Set ID 41ad0d3a-0704-44c9-e063-6394a90ad40d
Route
TOPICAL
Published
Effective Date 2025-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Pyrithione (0.02 g)
Inactive Ingredients
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 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Active ingredient Pyrithione zinc 2%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.

• scalp irritation and itching • flaking • scaling

Dosage and Administration

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.

Description

Active ingredient Pyrithione zinc 2%

Section 42229-5

ADVANCED RELIEF

Denorex®

SEVERE FLAKES

MEDICATED ANTI-DANDRUFF

SHAMPOO + CONDITIONER

DISTRIBUTED BY NEOTERIC COSMETICS, INC.

NEW YORK, NY 10003 / MADE IN CANADA

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50569-3

Ask a doctor before use if you have a condition that covers a large area of the body.

Section 51727-6

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

Section 51945-4

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)

Section 53413-1

Questions? Call 1-888-398-1382

email [email protected] or visit www.denorex.com

Section 55105-1

Purposes

Anti-dandruff, anti-seborrheic dermatitis

Section 55106-9

Active ingredient

Pyrithione zinc 2%

Other Information

Store at 68-77°F (20-25°C)


Structured Label Content

Indications and Usage (34067-9)

Uses

Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.

• scalp irritation and itching • flaking • scaling

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

ADVANCED RELIEF

Denorex®

SEVERE FLAKES

MEDICATED ANTI-DANDRUFF

SHAMPOO + CONDITIONER

DISTRIBUTED BY NEOTERIC COSMETICS, INC.

NEW YORK, NY 10003 / MADE IN CANADA

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a condition that covers a large area of the body.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions? Call 1-888-398-1382

email [email protected] or visit www.denorex.com

Section 55105-1 (55105-1)

Purposes

Anti-dandruff, anti-seborrheic dermatitis

Section 55106-9 (55106-9)

Active ingredient

Pyrithione zinc 2%

Other Information (Other information)

Store at 68-77°F (20-25°C)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)