Otc - Active Ingredient
Tolnaftate 1%
Dr. Anti Fungus
FDA Label NDC 65112-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I. Shay Cosmetics for the product Dr. Anti Fungus (NDC 65112-300). 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 otc - active ingredient, otc - purpose, indications & usage, inactive ingredient, warnings, dosage & administration, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal. Prevents athlete's foot with use.
Indications & Usage
For effective treatment of most athlete's foot (dermatophytosis). Relieves: Itching, burning, scaling, irritation, soreness.
Inactive Ingredient
Ethanol, Polysorbate 20, Polyethylene Glycol 300, Methylparaben.
Warnings
1. Do not use on children under 2 years of age unless directed by a doctor.
2. For external use only.
3. Avoid contact with the eye.
* If irritation occurs or there is no improvement within two weeks discontinue use and consult a doctor.
Dosage & Administration
Fill foot basin with warm water and add 1 oz of solution (1.5 tbsp) for every one gallon of water. Mix until water is diluted with the solution. Soak your feet for 5-10 minutes.
Otc - Keep Out Of Reach Of Children
WARNINGS - Keep children out of reach.
* Please review the disclaimer below.
