Label: FORTINIA ULTRA- clotrimazole 1% solution
- NDC Code(s): 54633-025-15
- Packager: The Podiatree Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
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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.
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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
- OTHER INFORMATION
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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)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORTINIA ULTRA
clotrimazole 1% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7) THYMUS VULGARIS (THYME) FLOWER/LEAF OIL (UNII: 2UK410MY6B) EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL (UNII: VCA5491KVF) POLYSORBATE 80 (UNII: 6OZP39ZG8H) UREA (UNII: 8W8T17847W) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) CINNAMOMUM ZEYLANICUM LEAF OIL (UNII: S92U8SQ71V) POLYSORBATE 20 (UNII: 7T1F30V5YH) CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL (UNII: 75IZZ8Y727) AQUA (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) CILANTRO (UNII: ICE9ZZM1HJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-025-15 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 12/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 11/10/2025 Labeler - The Podiatree Company (078656000)

