Tolnaftate Aerosol, Spray
FDA Label NDC 69256-034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Tolnaftate (NDC 69256-034). 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

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • prevents recurrence of athlete's foot with daily use
  • for effective relief of itching, cracking and burning

​Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling contents cans 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

Do Not Use

on children under 2 years of age unless directed by a doctor.

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)
  • 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
  • use daily for 4 weeks
  • if conditions persist, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

​Other Information

store between 20° and 30°C (68°F and 86°)

​Inactive Ingredients

BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

Questions?

call 1-888-423-0139

​Principal Display Panel

Harris Teeter

ANTIFUNGAL
athlete's foot
Liquid Spray
Tolnaftate

Cures most athlete's foot & prevents recurrences

Relieves itching, cracking & burning

NET WT 5.3 OZ (150 g)

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