Skip to content

Checked

OTC

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 formStrengthRouteNDCs
Liquid.3 g/30mLtopical1

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

All drug recalls

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