RoyceDerm Athletes foot antifungal .cream.
RoyceDerm Athletes foot antifungal .cream. is an FDA drug label for the active ingredient MICONAZOLE NITRATE 2% manufactured by RoyceDerm LLC 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 20260811.
- Generic name
- MICONAZOLE NITRATE 2%
- Manufacturer
- RoyceDerm LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 85424-031
- Application
- M005
- Label effective
- 20260811
About this product
RoyceDerm Athletes foot 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 85424-031, application M005, label effective 20260811. 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.
What it is used for
Across FDA labelling, products containing MICONAZOLE NITRATE 2% are most often described in connection with: affected area, well andlet, product sit, rinsing make, sure todry, thoroughly supervise, athlete foot, pay special. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Wash affected area well andlet product sit 2-3 minutes before rinsing. Make sure todry affected area thoroughly. Supervise children in the useof this product. For Athlete's foot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use1-2 times daily. Use daily for 4weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.
Dosage & Administration
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.
Warnings
For external use only. Avoid contact with the eye. Ask a doctor if irritation occurs or if there is no improvement within 2 weeks for athlete's foot and ringworm. Do not use on children under 2 of age except under the advice and supervision of a doctor. If swallowed, get medical help or contact a Poison Control Center right away.
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View labelHow products containing MICONAZOLE NITRATE 2% compare
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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Jiangxi Yudexi Pharmaceutical Co., LTD | 5 |
| — | — | Trovina Co. Ltd | 4 |
| — | — | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 4 |
| — | — | PureTek Corporation | 2 |
| — | — | REGENEREN PLUS LTD | 2 |
Frequently asked questions
What is RoyceDerm Athletes foot antifungal .cream. used for?
Wash affected area well andlet product sit 2-3 minutes before rinsing. Make sure todry affected area thoroughly. Supervise children in the useof this product. For Athlete's foot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use1-2 times daily. Use daily for 4weeks; if condition persists longer, ask a …
Who makes RoyceDerm Athletes foot antifungal .cream.?
RoyceDerm LLC is the labeler of record for RoyceDerm Athletes foot 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 Athletes foot 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 Athletes foot 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 Athletes foot 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.
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.