Otc - Active Ingredient
Pyrithione Zinc 2%
Dermazinc Shampoo
FDA Label NDC 35324-003
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 35324-003). 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
Anti-dandruff
Seborrheic Dermatitis treatment
Dosage & Administration
Apply to wet hair and massage into hair and scalp; rinse thoroughly
For best results use at least twice a week or as directed by a doctor.
Indications & Usage
For relief of the symptoms of seborrheic dermatitis and dandruff.
Warnings
Warnings
■ For external use only.
■ 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.
Inactive Ingredient
Inactive ingredients
ammonium laureth sulfate, ammonium lauryl sulfate, citric acid, cocamide DEA, cocamidopropyl
betaine, DMDM hydantoin, isopropyl alcohol, menthol, titanium dioxide, water, FD&C blue #2,
FD&C yellow #5
Package Label.Principal Display Panel
Dermazinc Shampoo (Dermazinc Shampoo Label New Page 001)
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