Otc - Active Ingredient
Active ingredient
Tolnaftate 1.0%.........................
Foot Works Healthy
FDA Label NDC 10096-0303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Foot Works Healthy (NDC 10096-0303). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Purpose
.......................Antifungal
Indications & Usage
Uses
• proven clinically effective in the treatment of most athlete’s foot (tinea pedis)
• relieves itching, burning feet
• prevents the recurrence of most athlete’s foot (tinea pedis) with daily use
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
• on children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product
• avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
• irritation occurs or if there is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• To treat athlete’s foot, clean the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Use daily for 4 weeks. If condition persists longer, consult a doctor. Not effective for infections of the nails or scalp.
• To prevent athlete’s foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
• Supervise children in the use of this product.
• Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, cotton socks, and change shoes and socks at least once daily.
Inactive Ingredient
Inactive ingredients
TALC, ZINC OXIDE, SODIUM SILICOALUMINATE, TRICALCIUM PHOSPHATE, METHYLPARABEN, SODIUM POLYACRYLATE, WATER/EAU.
Otc - Questions
QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada
* Please review the disclaimer below.
