Zolidyne

PYRITHIONE ZINC TOPICAL HUMAN OTC DRUG

Zolidyne is an FDA drug label for the active ingredient PYRITHIONE ZINC manufactured by Topiderm, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20191120.

Generic name
PYRITHIONE ZINC
Manufacturer
Topiderm, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
51326-203
Application
M032
Label effective
20191120

About this product

Zolidyne is an FDA-registered drug product whose active ingredient is PYRITHIONE ZINC. It is labelled by Topiderm, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51326-203, application M032, label effective 20191120. It is one of 64 FDA drug label records sharing the active ingredient PYRITHIONE ZINC. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing PYRITHIONE ZINC are most often described in connection with: gentle specially, formulated shampoo, control flaking, itching associated, dandruff seborrheic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Zinc Pyrithione, 2%

Indications & Usage

Uses A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Dosage & Administration

Directions Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes For best results, use at least twice a week or as directed by your doctor.

Warnings

Warnings For external use only Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water If condition worsens or does not improve after regular use of this product as directed, consult a doctor If condition covers a large area of the body, consult your doctor before using this product Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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How products containing PYRITHIONE ZINC compare

FDA lists 64 drug label records with PYRITHIONE ZINC as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — The Procter & Gamble Manufacturing Company 10
— — Wal-Mart Stores, Inc. 7
— — L'Oreal USA Products Inc 6
— — J. Strickland & Co. 5
— — Apollo Health and Beauty Care 4

Frequently asked questions

What is Zolidyne used for?
Uses A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.

Who makes Zolidyne?
Topiderm, Inc. is the labeler of record for Zolidyne. 64 FDA label records share the active ingredient PYRITHIONE ZINC, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Zolidyne come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Zolidyne prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PYRITHIONE ZINC?
Yes. 64 FDA drug label records list PYRITHIONE ZINC as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Zolidyne been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.