Active Ingredient
Clotrimazole 1%
Fortinia Of Solution
FDA Label NDC 54633-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Podiatree Company for the product Fortinia Of (NDC 54633-017). 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, purpose, uses, warnings, flammable, do not use, stop use and ask a doctor or pharmacist if, 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
Purpose
Antifungal
Uses
• cures most athlete’s foot infections and ringworm infections
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Warnings
For external use only
Flammable
Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor Or Pharmacist If
• irritation occurs
• there is no improvement within 4 weeks
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.
Directions
• wash affected area and dry thoroughly
• apply one drop to the affected area twice daily (morning and night) or as directed by your doctor
• using a disposable cotton swab, spread a thin layer over the affected area
• discard cotton swab
• supervise children in the use of this product
• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• for athlete’s foot and ringworm infections, use daily for 4 weeks
• this product is not effective on scalp or nails
Other Information
Store at controlled room temperature.
Inactive Ingredients
Ethyl Alcohol (79%), Propylene Glycol
Questions Or Suggestions?
1.855.763.8733 or visit us at www.thepodiatreecompany.com
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