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Denorex Severe Itch Shampoo
FDA Label NDC 62673-175
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 Itch (NDC 62673-175). 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 ingredients:, 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 Ingredients:
Coal Tar 1.8%
(from Coal Tar Topical Solution, USP 20%)
Purpose:
Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Uses:
Reduces and helps prevent recurrence of these symptoms of dandruff:
- scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff
Warnings:
For external use only
Ask A Doctor Before Use If You Have
a condition 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.
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, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40
Questions?
Call 1-888-398-1382
email [email protected] or visit www.denorex.com
Warning:
This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Package Label.Principal Display Panel
ADVANCED RELIEF
Denorex®
SEVERE ITCH
MEDICATED
ANTI-DANDRUFF
SHAMPOO + CONDITIONER
1.8 % Coal Tar / DANDRUFF,
SEBORRHEIC DERMATITIS + PSORIASIS
INSTANT SOOTHING RELIEF
CONTROLS & RELIEVES:
SEVERE ITCHING
SCALP DISCOMFORT
INFLAMMATION
FLAKING & SCALING
associated with dandruff, seborrheic dermatitis + psoriasis
1.8% COAL TAR
10 FL OZ (296 mL)
* Please review the disclaimer below.
