DENOREX SEVERE FLAKES MEDICATED ANTI DANDRUFF- pyrithione zinc shampoo

Denorex Severe Flakes by

Drug Labeling and Warnings

Denorex Severe Flakes by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 2%

PURPOSE

Purposes

Anti-dandruff, anti-seborrheic dermatitis

INDICATIONS & USAGE

Uses

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

scalp irritation and itching flaking scaling

WARNINGS

Warnings

For external use only.

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

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

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

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

DOSAGE & 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.

Other information

Store at 68-77°F (20-25°C)

INACTIVE INGREDIENT

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

QUESTIONS

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

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)

INGREDIENTS AND APPEARANCE

DENOREX SEVERE FLAKES  MEDICATED ANTI DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC PYRITHIONE (UNII: R953O2RHZ5) (ZINC PYRITHIONE - UNII:R953O2RHZ5)	ZINC PYRITHIONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRONELLOL (UNII: P01OUT964K)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LINALOOL (UNII: D81QY6I88E)
LINALYL ACETATE (UNII: 5K47SSQ51G)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
MENTHOL (UNII: L7T10EIP3A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCAMIDE MIPA (UNII: 21X4Y0VTB1)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPANOLAMINE (UNII: UE40BY1BZW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TERPINEOL (UNII: R53Q4ZWC99)
COUMARIN (UNII: A4VZ22K1WT)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-176-10	1 in 1 CARTON	01/01/2026
1		296 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/01/2026

Labeler - Neoteric Cosmetics, Inc. (790615181)