Otc - Active Ingredient
Active ingredient
Pyrithione zinc 2%
Denorex Severe Flakes Shampoo
FDA Label NDC 62673-176
Full FDA labeling including 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 Severe Flakes (NDC 62673-176). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Ask Doctor
Ask a doctor before use if you have a condition that covers a large area of the body.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
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
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
Otc - Questions
Questions? Call 1-888-398-1382
email [email protected] or visit www.denorex.com
Other
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)
* Please review the disclaimer below.
