Prosacea

Prosacea is an FDA-registered drug product whose active ingredient is SULPHUR. It is labelled by Kobayashi Healthcare International, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52389-173, label effective 20261030. It is one of 5 FDA drug label records sharing the active ingredient SULPHUR. 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 SULPHUR are most often described in connection with: treatment rosacea, redness acne. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the treatment of rosacea, redness, acne and other eruptions of the skin.

Directions Read all package directions and warnings before use. Use only as directed. Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer of Prosacea Gel one to three times daily. Massage gently until absorbed into the skin. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Intended for use by normally healthy adults only. Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Warnings For external use only

FDA lists 5 drug label records with SULPHUR 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 Prosacea used for?
Uses For the treatment of rosacea, redness, acne and other eruptions of the skin.

Who makes Prosacea?
Kobayashi Healthcare International, Inc. is the labeler of record for Prosacea. 5 FDA label records share the active ingredient SULPHUR, 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 Prosacea 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 Prosacea 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 SULPHUR?
Yes. 5 FDA drug label records list SULPHUR 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 Prosacea 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.