Tolnaftate
FDA Label NDC 61360-2020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals, Inc. for the product Tolnaftate (NDC 61360-2020). 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, when using this product, stop use and ask a doctor if, directions, for athlete's foot and ringworm, 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

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

For external use only.

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Directions

This product is not effective on the scalp or nails.

For Athlete's Foot And Ringworm

use daily for 4 weeks.

For Jock Itch

use daily for 2 weeks

  • clean the affected area and dry thoroughly
  • apply 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, change shoes and socks at least once daily.

Other Information

  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

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

Principal Display Panel - 30 G Label

Walgreens

NDC 03630-020-02

TOLNAFTATE Antifungal Cream

Tolnaftate Cream, 1%
NET WT 1 OZ (30 g)

Principal Display Panel (30 g Label)

Principal Display Panel (30 g Label)

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