Tinactin

Tolnaftate · Aerosol, Powder · Topical

Over the counter 4 recalls

Active ingredient

Active ingredient Tolnaftate 1%

Purpose

Purpose Antifungal

Uses

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, burning and cracking

Warnings

Warnings For external use only Do not use on children under 2 years of age except under the advice and supervision of a doctor. When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

When using this product

When using this product avoid contact with the eyes

Stop use and ask a doctor

Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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 use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails

Other information

Other information store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Inactive ingredients ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

Questions? 1-866-360-3266

Label text from the FDA structured product label by Bayer HealthCare LLC. (revised Dec 5, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Tinactin NDC products (7)

NDCStrength & formLabelerType
11523-0138Tolnaftate 10 mg/g
Aerosol, Powder
Bayer HealthCare LLCOTC MONOGRAPH DRUG
11523-0165Tolnaftate 10 mg/g
Aerosol, Spray
Bayer HealthCare LLCOTC MONOGRAPH DRUG
11523-0137Tolnaftate 10 mg/g
Aerosol, Powder
Bayer HealthCare LLC.OTC MONOGRAPH DRUG
11523-0139Tolnaftate 10 mg/g
Aerosol, Powder
Bayer HealthCare LLC.OTC MONOGRAPH DRUG
11523-0934Tolnaftate 10 mg/g
Cream
Bayer HealthCare LLC.OTC MONOGRAPH DRUG
11523-1190Tolnaftate 10 mg/g
Cream
Bayer HealthCare LLC.OTC MONOGRAPH DRUG
11523-4162Tolnaftate 10 mg/g
Aerosol, Powder
Bayer HealthCare LLC.OTC MONOGRAPH DRUG

Tinactin recalls

Frequently asked questions

What is Tinactin used for?

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, burning and cracking

Who makes Tinactin?

Tinactin is listed by 2 labelers in the FDA NDC directory, including Bayer HealthCare LLC, Bayer HealthCare LLC..

Has Tinactin been recalled?

The FDA enforcement database lists 4 recalls for Tinactin, most recently D-0242-2022 (class ii): cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.