Tolnaftate Aerosol, Spray
FDA Label NDC 81522-068

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. for the product Tolnaftate (NDC 81522-068). 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, ​keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

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 open flame. Do not puncture or incinerate container.Do not store at temperature above 120°F. Keep out fo reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling 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.

​Keep Out Of 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 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 ring worm, 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, clear 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

caring mill​

Antifungal

Athlete's Foot

Liquid Spray

Antifungal/Tolnaftate 1%

Cures most athlete's foot and prevents recurrences

Relieves itching, cracking and burning

Net WT 5.3 OZ. (150g)

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