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Drug Facts
Fortinia Cream
FDA Label NDC 54633-314
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 (NDC 54633-314). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Clotrimazole 1%
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
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 eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
- irritation occurs
- 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.
Directions
- wash affected area and dry thoroughly
- apply a thin layer to the affected area twice daily (morning and night)
- 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 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
Other Information
Store at controlled room temperature
Questions Or Suggestions?
1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not
completely satisfied, please contact us directly for a full refund.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water
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