Tolnaftate Antifungal
FDA Label NDC 76413-321

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Tolnaftate Antifungal (NDC 76413-321). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

Warnings

For external use only

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Otc - Keep Out Of Reach Of Children

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
  • apply 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 condition persists longer, ask 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° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Questions?

Call 1-866-923-4914

How Supplied

Product: 76413-321

NDC: 76413-321-15 15 g in a TUBE

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