"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
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.
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. Revised: Feb 2015
Last reviewed on RxList: 3/24/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Jublia Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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