FDA Label for Anti-fungal Cream
View Indications, Usage & Precautions
Anti-fungal Cream Product Label
The following document was submitted to the FDA by the labeler of this product World Wide Services Limited Liability Company. 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.
Active Ingredient
Clotrimazole USP 1% w/w
Purpose
Antifungal Cream
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Uses
Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Warnings
● For external use only
● Do not use on children under 2 years of age unless directed by a doctor.
● Avoid contact with eyes.
● If irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Directions
- Wash the affected area and dry thoroughly.
● Apply a thin layer of this product over 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.
● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
● If conditions persists longer, consult a doctor.
● This product is not effective on the scalp or nails.
Stop Use And Ask A Doctor If
- Irritation occurs
- There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
Inactive Ingredients
Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water
Other Information
- store at controlled room temperature 15°-30°C (59°- 86°F)
- Close cap tightly after use.
FootCure® Clotrimazole Anti-Fungal Cream is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin® AF.
Questions
Adverse Event call 1 888 296 9067
For questions, refund or replacment needed please contact us [email protected]
www.myfootcure.com
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