Terpenicol Antifungal Solution

Terpenicol Antifungal Solution is an FDA-registered drug product whose active ingredient is MICONAZOLE NITRATE. It is labelled by Blaine Labs Inc. taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 63347-380, application M005, label effective 20260701. It is one of 70 FDA drug label records sharing the active ingredient MICONAZOLE 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 MICONAZOLE NITRATE are most often described in connection with: athlete foot, tinea pedis, corporis relieves, discomfort irritation, itching cracking, scaling skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Relieves discomfort, irritation, itching, cracking, burning, and scaling skin, which accompany these conditions

Directions: ■ Wash the affected area and dry thoroughly ■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor ■ Supervise children in the use of this product ■ For athlete’s foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ For athlete’s foot and ringworm, use daily for 4 weeks ■ If condition persists longer, consult a doctor ■ This product is not effective on the scalp or nails. ■ Wash hands before and after use.

Warnings - For external use only Do not use on children under 2 years of age unless directed by a physician. Do not use in or near the mouth or eyes. When using this product: avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm

FDA lists 70 drug label records with MICONAZOLE 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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Terpenicol Antifungal Solution used for?
Uses ■ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Relieves discomfort, irritation, itching, cracking, burning, and scaling skin, which accompany these conditions

Who makes Terpenicol Antifungal Solution?
Blaine Labs Inc. is the labeler of record for Terpenicol Antifungal Solution. 70 FDA label records share the active ingredient MICONAZOLE 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 Terpenicol Antifungal Solution come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Terpenicol Antifungal Solution 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?
Yes. 70 FDA drug label records list MICONAZOLE 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 Terpenicol Antifungal Solution been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.