INDICATIONS AND USAGE Jublia (8ml) 10%
Jublia (8ml) 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.
DOSAGE AND ADMINISTRATION
• 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.
DOSAGE FORMS AND STRENGTHS
The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain.
HOW SUPPLIED/STORAGE AND HANDLING
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution supplied in a white plastic bottle with an integrated flow-through brush applicator as follows:
• 4 mL (NDC 0187-5400-04)
• 8 mL (NDC 0187-5400-08)
Storage and Handling Conditions: Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature].
• Solution is flammable; keep away from heat or flame
• Protect from freezing
• Keep out of the reach of children
• Keep bottle tightly closed
• Store in upright position
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information)
• JUBLIA is for external use only and is not for ophthalmic, oral, or intravaginal use. It is for use on toenails and immediately adjacent skin only.
• Apply JUBLIA once daily to clean dry toenails. Wait for at least 10 minutes after showering, bathing, or washing before applying.
• Use JUBLIA only on the affected toenails, as directed by your healthcare provider.
• Inform a health care professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling).
• Avoid pedicures, the use of nail polish, and cosmetic nail products while using JUBLIA.
• Flammable, avoid use near heat or open flame.