Thera Plus Antifungal Tolnaftate Cream
FDA Label NDC 80684-040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Antifungal Tolnaftate (NDC 80684-040). 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 ask 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

Anti-Fungal

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.

Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor.

When Using This Product

avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks.

Keep Out Of Reach Of Children.

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

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-ftting, 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 at room temperature 20° to 25°C (68° to 77°F)
  • lot no & expiration date: see box or crimp of tube

Inactive Ingredients

cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

Questions?

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