TEA TREE Oil DANDRUFF

TEA TREE Oil DANDRUFF is an FDA-registered drug product whose active ingredient is PYRITHIONE ZINC. It is labelled by Universal Distribution Center LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52000-455, application M032, label effective 20260818. 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.

Across FDA labelling, products containing PYRITHIONE ZINC are most often described in connection with: helps remove, relieve itching, gently cleansing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES helps remove flakes and relieve itching associated with dandruff while gently cleansing hair and scalp.

DIRECTIONS • Shake well before use. • Wet hair thoroughly, apply shampoo to scalp, and massage gently. • Rinse thoroughly and repeat if desired. • For best results, use at least twice weekly or as directed by a doctor.

WARNINGS For external use only. WHEN USING THIS PRODUCT • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation occurs or condition worsens after regular use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

What is TEA TREE Oil DANDRUFF used for?
USES helps remove flakes and relieve itching associated with dandruff while gently cleansing hair and scalp.

Who makes TEA TREE Oil DANDRUFF?
Universal Distribution Center LLC is the labeler of record for TEA TREE Oil DANDRUFF. 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 TEA TREE Oil DANDRUFF 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 TEA TREE Oil DANDRUFF 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 TEA TREE Oil DANDRUFF 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.