Clarus Ac Antifungal Solution Liquid
FDA Label NDC 44577-128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Therapeutic Solutions for the product Clarus Ac Antifungal Solution (NDC 44577-128). 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

Topical Antifungal

Uses:

  • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm). 
  • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections. 
  • Prevents most tinea pedis (athlete's foot) with daily use.

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 Ask A Doctor If

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep Out Of Reach Of Children.

If swallowed, 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 affected area twice daily (morning and night) or as directed by a doctor. 
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.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.
  • This product is not effective on the scalp or nails.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

N-Acetylcysteine, Beeswax, Dimethyl Isosorbite, Helianthus Annuus (Sunflower) Oil, Lactic Acid, Tocopheryl Acetate (Vitamin E), Undecylenic Acid, Urea.

Questions?

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