Active Ingredient
Tolnaftate 1%
Tolnaftate Aerosol, Spray
FDA Label NDC 79481-0591
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Tolnaftate (NDC 79481-0591). 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 most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- prevent 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 pressue. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120F. Keep out of reach of children. Use only as directed. Intentional misuse by dilberately 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 Reach Od Children.
If swallowed, get medical hel 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 800-824-1706 Monday - Friday 9am - 4pm MST
Principal Display Panel
Antifungal
Liquid Spray
Tolnaftate 1%/
ANTIFUNGAL
- Cures Most Athlete's Foot & Prevents Recurrences
- Relieves Itching, Cracking & Burning
NET WT 5.3 OZ (150g)
* Please review the disclaimer below.
