Other
Drug Facts
EXTRA STRENGTH
Denorex®
MULTI-SYMPTOM
MEDICATED ANTI-DANDRUFF
SHAMPOO + CONDITIONER
DISTRIBUTED BY NEOTERIC COSMETICS, INC.
NEW YORK 10003 / MADE IN USA
Denorex Extra Strength Shampoo
FDA Label NDC 62673-059
14 label sections · Submitted to the FDA by Neoteric Cosmetics, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neoteric Cosmetics, Inc. for the product Denorex Extra Strength (NDC 62673-059). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Salicylic acid 3%
Purpose
Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Uses
Reduces and helps prevent recurrence of these symptoms of dandruff, seborrheic dermatitis and psoriasis.
• scalp irritation and itching • flaking • scaling
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.
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.
Other Information
Store at 68-77° F (20-25° C)
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)
Questions?
Call 1-888-398-1382
email [email protected] or visit www.denorex.com
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)
* Please review the disclaimer below.
