Tolfyra

Tolfyra is an FDA-registered drug product whose active ingredient is TOLNAFTATE. It is labelled by Oncora Pharma, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85477-331, application M005, label effective 20260511. It is one of 53 FDA drug label records sharing the active ingredient TOLNAFTATE. 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 TOLNAFTATE are most often described in connection with: athlete foot, tinea pedis, corporis relieves, itching burning, cracking scaling, eliminates fungus, fingers toes, helps stop. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Directions ■ clean the affected area and dry thoroughly ■ apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails 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. Use under the direction of a medical practitioner

Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product ■ do not get into eyes Stop use and ask a doctor ■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks ■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 53 drug label records with TOLNAFTATE 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 Tolfyra used for?
Uses ■ for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). ■ relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. ■ for the prevention of most Athlete’s foot with daily use. ■ eliminates fungus on fingers, toes, and around the nails. ■ eliminates and helps stop the spread of fungal infections on cuticles around nail …

Who makes Tolfyra?
Oncora Pharma, LLC is the labeler of record for Tolfyra. 53 FDA label records share the active ingredient TOLNAFTATE, 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 Tolfyra 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 Tolfyra 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 TOLNAFTATE?
Yes. 53 FDA drug label records list TOLNAFTATE 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 Tolfyra 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.