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Molecule

Efinaconazole

Azole Antifungal
Available on requestDermatology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Efinaconazole is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. It is available as topical solution. MedsAcross supplies Efinaconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Azole Antifungal
ATC classification
D01AC19 Efinaconazole · Antifungals for the skin, subgroup D01A, subgroup D01AC
US FDA first approval
6 June 2014
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Topical solution
Identifiers
UNII J82SB7FXWBRxCUI 1539753CAS 164650-44-6DrugBank DB09040Q21011225

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Source: US FDA prescribing information

Dosing overview

Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply JUBLIA to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator. • When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. • For topical use only. Not for oral, ophthalmic, or intravaginal use.

Source: US FDA prescribing information

Side effects

The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain.

Source: US FDA prescribing information

Interactions

In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Source: US FDA prescribing information

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). • Solution is flammable, keep away from heat or flame. • Protect from freezing. • Keep out of reach of children. • Keep bottle tightly closed. • Store in upright position.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Efinaconazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Jublia 100 mg/mL topical solutionTopicalBausch HealthUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 6 June 2014Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Efinaconazole available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Efinaconazole and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Efinaconazole have?

The catalogue lists 1 brand names for Efinaconazole, including Jublia.

Is Efinaconazole approved by the US FDA?

Yes. The US FDA first approved Efinaconazole on 6 June 2014, according to Drugs@FDA.

Does Efinaconazole need cold chain shipping?

No listed presentation of Efinaconazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Efinaconazole in?

Efinaconazole is classified under ATC code D01AC19 (Efinaconazole).

References

  1. JUBLIA prescribing information (Bausch Health). U.S. National Library of Medicine, DailyMed. Retrieved 1 July 2025

Request Efinaconazole for export supply

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