Active Ingredient
Tolnaftate 1%
Tolnaftate Aerosol, Spray
FDA Label NDC 11822-0780
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Tolnaftate (NDC 11822-0780). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, flammable:, when using this product, stop use and ask a doctor if, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
- prevents the recurrence of most athlete's foot with daily use
- for effective relief of itching, cracking and burning
Warnings
For external use only.
Flammable:
Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or flame. Do not puncture or incinerate container. Do not store at temperature above 120°F. Keep out of the reach of children. Use only as directed. Intentional misuse by delibrately concentrating and inhaling the contents can be harmful or fatal.
When Using This Product
- avoid contact with the eyes or mouth
- use only as directed
Stop Use And Ask A Doctor If
- irritation occurs
- no improvement within 4 weeks for athlete's foot and ringworm
Do Not Use
on children under 2 years of age unless directed by a doctor.
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- wash affected area and dry thoroughly
- shake can well and spray a thin layer of the product over 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, consult a doctor
- to prevent athlete's foot: wash the feet and dry thoroughly; spray a thin layer of the product to the feet once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
- if nozzle clogs, clean with a pin
Other Information
store between 20° and 30°C (68° and 86°F)
Inactive Ingredients
BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B
Questions?
Call 1-866-964-0939
Principal Display Panel
Antifungal
Liquid Spray
tolnaftate 1%
Cures most athlete's foot & prevents recurrences
Relieves itching, cracking & burning
NET WT 5.3 OZ (150g)
Tolnaftate Liquid Spay (E63e1d32 4b77 40ac 8ab4 93d3393f2c32)
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