FDA.reportPublic FDA data

Fortinia Ultra Antifungal Solution

Manufacturer
The Podiatree Company
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:01

Label at a glance#

ProductFortinia Ultra
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Indications and uses

Uses • Cures athlete’s foot (dermatophytosis) and ringworm (tinea corporis) • Relieves • itching • burning • cracking • scaling • discomfort

Dosage and administration

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 c...

Storage and handling

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).

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

USES

INDICATIONS & USAGE SECTION

Uses
• Cures athlete’s foot (dermatophytosis) and ringworm (tinea corporis)
• Relieves • itching • burning • cracking • scaling • discomfort

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309370clotrimazole 1 % Topical SolutionPSN2
309370clotrimazole 10 MG/ML Topical SolutionSCD2
309370clotrimazole 1 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-025-15Fortinia Ultra15 mL in 1 BOTTLE, DROPPERSOLUTION152

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54633-02554633-025-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
CYMBOPOGON FLEXUOSUS LEAF7LJ4Y1UJG7IACT
THYMUS VULGARIS (THYME) FLOWER/LEAF OIL2UK410MY6BIACT
EUGENIA CARYOPHYLLUS (CLOVE) LEAF OILVCA5491KVFIACT
POLYSORBATE 806OZP39ZG8HIACT
UREA8W8T17847WIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CINNAMOMUM ZEYLANICUM LEAF OILS92U8SQ71VIACT
POLYSORBATE 207T1F30V5YHIACT
CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL75IZZ8Y727IACT
AQUA059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CILANTROICE9ZZM1HJIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
ndc (package): 54633-025-15
ndc (product): 54633-025
ndc11 (package): 54633002515
spl id: 43065a59-fb82-b1c2-e063-6294a90a36e0
spl set id: 43065a59-fb81-b1c2-e063-6294a90a36e0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.