FDA Label for Denorex Severe Flakes Medicated Anti Dandruff
View Indications, Usage & Precautions
Denorex Severe Flakes Medicated Anti Dandruff Product Label
The following document was submitted to the FDA by the labeler of this product Neoteric Cosmetics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient
Pyrithione zinc 2%
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.
