Indications and Important Safety Information
LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older.
LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use.
LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when LUZU is prescribed for nursing mothers.
The most common adverse reactions in clinical trials were application site reactions, which occurred in less than 1% of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity.
To report SUSPECTED ADVERSE REACTIONS contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit http://www.fda.gov/medwatch.
Reference: 1. LUZU [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.
Luzu is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
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