Tolnaftate Aerosol, Spray
FDA Label NDC 79903-015

14 label sections · Submitted to the FDA by Wal-mart Stores, Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc for the product Tolnaftate (NDC 79903-015). 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, ​extremely flammable:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most 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.

​Extremely Flammable:

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

When Using This Product

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

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.

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
  • to prevent athlete’s foot, shake can well and spray a thin layer of the product to the feet once or twice daily (morning and/or 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
  • for athlete's foot and ringworm, use daily for 4 weeks
  • if condition persists, consult a doctor
  • this product is not effective on the scalp or nails

​Other Information

  • store between 20° and 30°C (68° and 86°F)
  • if nozzle clogs, clean with a pin

​Inactive Ingredients

ISOBUTANE, SD ALCOHOL 40-B, PPG-12-BUTETH-16, BHT

​Questions?

1-888-287-1915

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