Antifungal Liquid
FDA Label NDC 70000-0680

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leader/cardinal Health 110, Inc. for the product Antifungal Liquid (NDC 70000-0680). 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 consult 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) and ringworm (tinea corporis)

prevents the recurrence of most athlete's foot with daily use

for effective relief of itching, burning, cracking, redness and scaling

Warnings

For external use only.

Do Not Use

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

When Using This Product

avoid contact with the eyes.

Stop Use And Consult A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks

Keep Out Of Reach Of Children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

​Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the 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, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks.
  • if condition persists longer, consult a doctor
  • to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

​Other Information​

  • SHAKE WELL BEFORE USE
  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing; if freezing occurs, warm to room temperature
  • keep tightly closed when not in use

​Inactive Ingredient

WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM

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