Tolnaftate Spray
FDA Label NDC 0363-1746

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Company for the product Tolnaftate (NDC 0363-1746). 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, do not use, 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)
  • ringworm (tinea corporis)
  • effectively soothes and relieves
  • itching
  • burning
  • cracking
  • helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only

Flammable: Do not use near flame or spark or while smoking.

Do Not Use

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

When Using This Product

  • avoid contact with the eyes
  • contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
  • 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

  • clean the affected area and dry thoroughly
  • shake can well before use
  • hold can about 6 inches from the area to be treated
  • spray a thin layer over the 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 condition lasts longer, ask a doctor.
  • to prevent athlete’s foot, apply to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
  • in case of clogging, clean nozzle with a pin

Inactive Ingredients

alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Athlete’s Foot

Antifungal

Powder Spray

Tolnaftate 1%

Cures & prevents most athlete’s foot

Relieves itching & burning

NET WT 4.6 OZ (130g)

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