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  5. Label Information: Foot Works Healthy Antifungal

FDA Label for Foot Works Healthy Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. OTC - QUESTIONS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foot Works Healthy Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product New Avon Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient
Tolnaftate 1.0%.........................


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.