Exelderm

Exelderm is an FDA-registered drug product whose active ingredient is SULCONAZOLE NITRATE. It is labelled by Journey Medical Corporation taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 69489-721, application NDA018738, label effective 20260608. It is one of 3 FDA drug label records sharing the active ingredient SULCONAZOLE NITRATE. 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 SULCONAZOLE NITRATE are most often described in connection with: treatment tinea, usually occurs, usage exelderm, sulconazole nitrate, usp solution, broad-spectrum antifungal, agent indicated, corporis caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.

DOSAGE AND ADMINISTRATION A small amount of solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting EXELDERM (sulconazole nitrate) SOLUTION, 1.0%, and clinical improvement usually occurs within 1 week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks. If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.

CONTRAINDICATIONS EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

ADVERSE REACTIONS There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.

FDA lists 3 drug label records with SULCONAZOLE NITRATE 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 Exelderm used for?
INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). …

Who makes Exelderm?
Journey Medical Corporation is the labeler of record for Exelderm. 3 FDA label records share the active ingredient SULCONAZOLE NITRATE, 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 Exelderm 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 Exelderm prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SULCONAZOLE NITRATE?
Yes. 3 FDA drug label records list SULCONAZOLE NITRATE 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 Exelderm 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.