Active Ingredient
Tolnaftate 1%
Athletes Foot Solution/ Drops
FDA Label NDC 83837-002
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 Athletes Foot (NDC 83837-002). 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, warnings, ask a doctor, stop use, inactive ingredient, other information, purpose, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Ask A Doctor
If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
Stop Use
If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
Inactive Ingredient
Inactive Ingredients Almond Oil, Alpha-Bisabolene,
Calendula Officinalis Flower, Chamomile, Chlorphenesin,
Glycerin, Methyl-Gluceth-20, Phenoxyethanol, Piroctone
Olamine, Polysorbate 20, Polyethylene Glycol 400,
Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Water
Other Information
Store between 20 C and 30 C (68 F and 86 F)
Purpose
Antifungal
Directions
- Wash 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.
- Supervise children in the use of this product.
- Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- If condition persists longer, consult a doctor.
Keep Out Of Reach Of Children
Supervise children in the use of this product
Use
Cures most Athlete's Foot
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