RoyceDerm Tinea Antifungal Cream

RoyceDerm Tinea Antifungal Cream is an FDA-registered drug product whose active ingredient is MICONAZOLE NITRATE 2%. It is labelled by RoyceDerm LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85424-011, application M005, label effective 20260506. It is one of 24 FDA drug label records sharing the active ingredient MICONAZOLE NITRATE 2%. 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 MICONAZOLE NITRATE 2% are most often described in connection with: effective treatment, athlete foot, tinea pedis, jock itch, relief itching, cracking skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

- For effective treatment of most athlete's foot(tinea pedis), ringworm( tinea corporis) and jock itch(tinea cruris). - For effective relief of itching, burning and cracking skin

Wash the affected area anddry thoroughly. Apply a thinlayer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For Athlete'sfoot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoesand change shoes and socks atleast once daily. For athlete'sfoot and ringworm, use daily for4 weeks. For jock itch, usedaily for 2 weeks. If condition persists longer, ask a doctor.This product is not effective onthe scalp or nails.

For external use only Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 24 drug label records with MICONAZOLE NITRATE 2% 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 RoyceDerm Tinea Antifungal Cream used for?
- For effective treatment of most athlete's foot(tinea pedis), ringworm( tinea corporis) and jock itch(tinea cruris). - For effective relief of itching, burning and cracking skin

Who makes RoyceDerm Tinea Antifungal Cream?
RoyceDerm LLC is the labeler of record for RoyceDerm Tinea Antifungal Cream. 24 FDA label records share the active ingredient MICONAZOLE NITRATE 2%, 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 RoyceDerm Tinea Antifungal Cream 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 RoyceDerm Tinea Antifungal Cream 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 MICONAZOLE NITRATE 2%?
Yes. 24 FDA drug label records list MICONAZOLE NITRATE 2% 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 RoyceDerm Tinea Antifungal Cream 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.