FDA Label for Flexitol Medicated Foot
View Indications, Usage & Precautions
Flexitol Medicated Foot Product Label
The following document was submitted to the FDA by the labeler of this product Lacorium Health International Pty Ltd. 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.
Other
Drug Facts
USA DISTRIBUTOR:
LaCorium Health USA Inc.,
Boca Raton, Florida 33487
MANUFACTURED FOR:
LaCorium Health International Pty Ltd.,
Level 14, Tower 2,
101 Grafton Street,
Bondi Junction NSW 2022, Australia
Active Ingredient
Tolnaftate 1%
Purpose
Antifungal
Uses
- Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use
- For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.
Otc - Do Not Use
- Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
- For External Use Only
- Avoid contact with eyes
Otc - Stop Use
- If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor
Otc - Keep Out Of Reach Of Children
- Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.
Directions
- Clean the affected area and dry thoroughly
- Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor
- Supervise children in the use of this product
- For Athlete's Foot: pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
- Use daily for 4 weeks. If condition persists longer consult a doctor.
- To prevent Athlete's Foot, apply once or twice daily (morning and/or night)
- This product is not effective on the scalp or nails
- Replace cap and tighten after each use.
Other Information
- Store between 50°- 86°F in a dry place
Inactive Ingredients
Aloe, Benzalkonium Chloride, Cetearyl Alcohol, Ceteth-20, Cetyl Alcohol, Glycerin, Lavandula, Angustifolia (Lavender) Oil, Menthol, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Sodium Phosphate, Tocopherol, Urea, Water
Questions Or Comments?
Call Toll Free 1-866-478-3338
[email protected]
www.flexitol.com
Principal Display Panel - 56 G Tube Carton
Flexitol®
Medicated
Foot Cream
For treatment of
athlete's foot
Before
After 2 Weeks
APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION
With Aloe & Vitamin E
DIABETIC FRIENDLY
Net Wt 2 oz (56 g)
* Please review the disclaimer below.