Active Ingredients
Clotrimazole 1%
Fortinia Ultra Solution
FDA Label NDC 54633-025
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 Ultra (NDC 54633-025). 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 ingredients, purpose, uses, directions, warnings, precautions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Uses
• Cures athlete’s foot (dermatophytosis) and ringworm (tinea corporis)
• Relieves • itching • burning • cracking • scaling • discomfort
Directions
Wash 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 your doctor. 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, use daily for 4 weeks. If condition persists longer, consult your doctor. This product is not effective on the scalp or nails.
Warnings
• Do not use on children under 2 years of age unless directed by a doctor.
• For external use only
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
• If swallowed, get medical help or contact a Poison Control Center right away.
Precautions
Keep out of reach of children.
Other Information
Store at room temperature (68°-77°F). Using the brush provided or a disposable cotton swab, spread the liquid on the desired area. After each application, wash and dry brush thoroughly (or discard cotton swab).
Inactive Ingredients
Alcohol Denat., Caprylic/Capric Triglyceride, Cinnamomum Camphora (Camphor) Bark Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Coriandrum Sativum (Cilantro) Leaf/Stem Oil, Cymbopogon Flexuosus (Lemongrass) Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Polysorbate 20, Polysorbate 80, Thymus Vulgaris (Thyme) Leaf Oil, Urea, Water (Aqua)
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