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Jublia

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Since 2009, the Food and Drug Administratio"...

Jublia

Indications
Dosage
How Supplied

INDICATIONS

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.

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.

JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED

Dosage Forms And Strengths

JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale yellow solution.

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

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan Product of Japan. Issued: 06/2014

Last reviewed on RxList: 6/19/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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