Tolnaftate Aerosol, Spray
FDA Label NDC 67091-391

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Tolnaftate (NDC 67091-391). 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 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 pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Contents under pressure. 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

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
  • 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)

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