Active Ingredient
Tolnaftate
Toe Fungus Solution
FDA Label NDC 83837-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imperial Feet B.v. for the product Toe Fungus (NDC 83837-001). 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, ask a doctor, purpose, use, keep out of reach of children, stop use section, directions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask A Doctor
If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor
Purpose
Antifungal
Use
Cures most fungus on toes
Keep Out Of Reach Of Children
Supervise children in the use of this product.
Stop Use Section
If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
Directions
- Wash the affected area and dry thoroughly.
- Apply a thin layer of the product over affected are twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- If condition persists longer, consult a doctor.
Warnings
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only.
- Avoid contact with the eyes.
- If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
Other Information
Store between 20 C and 30 C (68 F and 86 F)
Inactive Ingredients
Alpha-Bisabolene, Chlorphenesin, Glycerin, Horse Chestnut, Jojoba Oil, Methyl Gluceth-20, Phenoxyethanol, Piroctone Olamine, Polyethylene Glycol 400, Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Tea Tree Oil, Water
* Please review the disclaimer below.
