Pyrithione Zinc
Pyrithione Zinc is an FDA drug label for the active ingredient CVS manufactured by Apollo Health and Beauty Care 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 20260503.
- Generic name
- CVS
- Manufacturer
- Apollo Health and Beauty Care
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 63148-211
- Application
- M032
- Label effective
- 20260503
About this product
Pyrithione Zinc is an FDA-registered drug product whose active ingredient is CVS. It is labelled by Apollo Health and Beauty Care taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63148-211, application M032, label effective 20260503. 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 CVS are most often described in connection with: helps prevent, recurrence scalp, itching flaking, andredness associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Helps prevent recurrence of scalp itching, flaking andredness associated with dandruff.
Dosage & Administration
Directions for best results, use at least twice weekly or as directed by the physician. Apply to wet skin and/or scalp and massage to form a lather. Leave lather on for few minutes. Rinse thoroughly and repeat if necessary.
Warnings
Warnings For external use only When using this product avoid contact with eyes. If contact occurs, rise eyes thoroughly with water. Stop use and ask a doctor if condition worsen or does not improve after regular use of this product as directed. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Comtrol Center immediately.
Recall and safety notices
3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0088-2021 | (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001 | Milbar Laboratories, Inc. | Class II | Terminated | 20201125 |
| D-1337-2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097 | A.P. Deauville, LLC | Class II | Terminated | 20200701 |
| D-0134-2017 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC | Taro Pharmaceuticals U.S.A., Inc. | Class III | Terminated | 20161116 |
Frequently asked questions
What is Pyrithione Zinc used for?
Uses Helps prevent recurrence of scalp itching, flaking andredness associated with dandruff.
Who makes Pyrithione Zinc?
Apollo Health and Beauty Care is the labeler of record for Pyrithione Zinc.
What form does Pyrithione Zinc 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 Pyrithione Zinc 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.
Has Pyrithione Zinc been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.