Tolnaftate Aerosol, Spray
FDA Label NDC 0363-0216

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Tolnaftate (NDC 0363-0216). 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

  • prevents recurrence of athlete's foot with daily use
  • cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • relieves sypmtoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Don not store at temperatures above 120 0F.

When Using This Product

  • avoid contact with the eyes or mouth
  • use only as directed
  • Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

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)
  • in case of clogging, clear nozzle under running water

Other Information

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

Inactive Ingredients

disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate

Questions?

call 1-866-964-0939

Principal Display Panel

Well at Walgreens

MEDICATED . ANTIFUNGAL

ODOR CONTROL POWDER SPRAY

Tolnaftate 1%

  • Cures & prevents most athlete's foot
  • Reduces odors

    • NET WT 4 OZ (113g)

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