What is Norvlia?
Norvlia is a prescription medicine used to treat fungal infections of the toenails.
It is not known if Norvlia is safe and effective for use in children under 6 years of age.
What are the possible side effects of Norvlia?
Norvlia may cause irritation at the treated site. The most common side effects include:
ingrown toenail,
redness,
itching,
swelling,
burning or stinging,
blisters, and
pain
Tell your healthcare provider if you have any side effects that bother you or that do not go away.
These are not all the possible side effects of Norvlia.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DESCRIPTION
Norvlia (efinaconazole) topical solution, 10% is a clear colorless to pale yellow solution for topical use. Each gram of Norvlia contains 100 mg of efinaconazole. Efinaconazole is an azole antifungal with a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol- 1-yl) butan-2-ol). The structural formula for efinaconazole is represented below:
Norvlia® (efinaconazole) Structural Formula Illustration
Molecular Formula: C18H22F2N4O Molecular Weight: 348.39
Norvlia contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
INDICATIONS
Norvlia (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.
DOSAGE AND ADMINISTRATION
Apply Norvlia to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying Norvlia, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.
Norvlia is for topical use only and not for oral, ophthalmic, or intravaginal use.
HOW SUPPLIED
Dosage Forms And Strengths
Norvlia (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale yellow solution.
Storage And Handling
Norvlia (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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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.