Denorex Extra Strength
Denorex Extra Strength with Conditioner
21d234ff-f379-4bcd-9ba0-90f27c6d3a69
HUMAN OTC DRUG LABEL
Apr 29, 2025
Neoteric Cosmetics, Inc.
DUNS: 790615181
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Salicylic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
Denorex®
MULTI-SYMPTOM
MEDICATED
ANTI-DANDRUFF
SHAMPOO + CONDITIONER
SALICYLIC ACID 3% / DANDRUFF, SEBORRHEIC DEMATITIS + PSORIASIS
EFFECTIVE RELIEF OF 6 DANDRUFF SYMPTOMS
FLAKING & SCALING
DRYNESS
SCALP BUILDUP
IRRITATION
ITCHING
REDNESS
associated with dandruff, seborrheic dermatitis + psoriasis
3% SALICYLIC ACID
10 FL OZ. (296 ml)
INDICATIONS & USAGE SECTION
Uses
Reduces and helps prevent recurrence of these symptoms of dandruff, seborrheic dermatitis and psoriasis.
• scalp irritation and itching • flaking • scaling
DOSAGE & ADMINISTRATION SECTION
Directions
- 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.
SPL UNCLASSIFIED SECTION
EXTRA STRENGTH
Denorex®
MULTI-SYMPTOM
MEDICATED ANTI-DANDRUFF
SHAMPOO + CONDITIONER
DISTRIBUTED BY NEOTERIC COSMETICS, INC.
NEW YORK 10003 / MADE IN USA
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Salicylic acid 3%
OTC - PURPOSE SECTION
Purpose
Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
WARNINGS SECTION
Warnings
For external use only.
Ask a doctor before use if you have
a condition that covers a large area of 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.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aqua\Water\Eau, Sodium C14-16 olefin sulfonate, PPG-2 Hydroxyethyl Cocamide, Propylene glycol, Glycol distearate, Menthol, Cocamidopropyl betaine, Fragrance\Parfum, Panthenol, Tocopheryl acetate, Glycerin, Dimethicone PEG-8 Meadowfoamate, Polyquaternium-10, Sodium chloride, Sodium citrate, Sodium hydroxide, CI 15985 (Yellow 6), CI 47005 (Yellow 10), CI 17200 (Red 33), CI 42090 (Blue 1)
OTC - QUESTIONS SECTION
Questions?
Call1-888-398-1382
email info@denorex.com or visit www.denorex.com