Otc - Active Ingredient
Pyrithione Zinc 2%
Dermazinc Soap
FDA Label NDC 35324-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wynnpharm Inc for the product Dermazinc (NDC 35324-004). 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 - keep out of reach of children, otc - purpose, dosage & administration, indications & usage, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children.
Otc - Purpose
Dandruff, Seborrheic Dermatitis treatment
Dosage & Administration
-Use on affected areas in place of regular soap.
-For best results, use at least twice a week, or as directed by your doctor.
-Work up a rich lather using warm water and massage gently into affected areas.
-Rinse well.
Indications & Usage
Controls, reduces and helps stop the symptoms of dandruff and seborrheic dermatitis.
Warnings
Warnings
■ Ask a doctor before use if you have a condition that covers a large area of the body.
When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with
water.
Stop use and ask a doctor if condition worsens or does not improve after regular use of this
product as directed.
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
■ For external use only.
Inactive Ingredient
Sodium Palmate, Sodium Cocoate, Water, Glycerin, Avena Sativa (Oat Kernel) Flour, Sodium Chloride, Grape Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Tetrasodium Glutamate Diacetate, Natural Vitamin E, Pentasodium Pentatate.
* Please review the disclaimer below.
