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Tolfyra
tolnaftate · Tolfyra is an over-the-counter drug containing tolnaftate, made by Oncora Pharma, LLC.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
■ 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. ■...
Drug facts
- Generic name
- tolnaftate
- Active ingredients
- Tolnaftate
- Dosage forms
- Liquid
- Label holder
- Oncora Pharma, LLC
- FDA application
- M005
- Label updated
- 05/11/2026
Active ingredients
Tolnaftate 1%
Purpose
Antifungal
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.
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.
How supplied
Tolfyra™ Tolnaftate 1% Antifungal Solution is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush (NDC 85477-331-01)
Inactive ingredients
The inactive ingredients in Tolvyra™ (tolnaftate 1% solution) are purified water, PEG-8, cetearyl alcohol, ceteth-20 phosphate, decetyl phosphate, propylene glycol, cocamidopropyl betaine, polysorbate 20, glyceryl stearate, stearyl alcohol, hydroxyethyl cellulose, imidazolidinyl urea, cetyl alcohol, methylparaben, propylparaben, triethanolamine, and citric acid.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Liquid | .3 g/30mL | topical | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 1,291 reports that list tolnaftate, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective117
- Pain93
- Fatigue86
- Nausea82
- Dyspnea74
- Anxiety66
- Diarrhea66
- Off label use59
- Headache57
- Vomiting54
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- Oncora Pharma, LLCShown hereM005 · Label 05/11/2026 · NDC 85477-331Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IDrug02/28/2024TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed...Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Chemical Contamination; presence of benzene.
- Class IDrug12/27/2023Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2...Blistex Inc · Chemical contamination: Presence of benzene
- Class IIDrug08/30/2023Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and...Ecometics, Inc. · CGMP Deviations: Products not manufactured under current good...
- Class IDrug11/24/2021LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by...Bayer Healthcare Pharmaceuticals Inc. · 12 products · cGMP Deviations: manufactured at the same facility where other...
Tolfyra: common questions
- What is Tolfyra used for?
- ■ 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. ■...
- Is Tolfyra a prescription drug?
- No. Tolfyra is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Tolfyra?
- Yes. Other FDA-listed products with the same active ingredients include Tolnaftate, Antifungal Liquid, Tolnafate, Maximum Strength Antifungal Liquid.
- Who makes Tolfyra?
- Oncora Pharma, LLC lists Tolfyra with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/11/2026 · Label text is shown as published by the manufacturer. Not medical advice