Maximum Strength Antifungal Liquid
FDA Label NDC 81522-077

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. for the product Maximum Strength Antifungal Liquid (NDC 81522-077). 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% w/w

​Purpose

Antifungal

Uses

  • For the treament of athlete's foot (tinea pedis) and ring worm (tinea corporis).
  • For effective relief of itching, scaling, cracking, burning, and redness.

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 eyes.

Stop Use And Consult A Doctor If

  • irritation occurs or if there is no improvement in 4 weeks.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

  • wash 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 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.
  • this product is not effective on the scalp or nails.

​Other Information​

  • store at room temperature 15°-30°C (59° - 86°F).
  • keep tightly closed when not in use.

​Inactive Ingredient

Acetone, Water, Propylene Glycol, Tocopherol Acetate.

Questions?

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