Efficacy demonstrated at 4 weeks post-treatment1

Proven efficacy to clear interdigital tinea pedis

Study Design: Two randomized, double-blind, vehicle-controlled, multicenter trials in 423 subjects with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Signs and symptoms of interdigital tinea pedis (erythema, scaling, and pruritus), KOH exam, and dermatophyte culture were assessed at baseline, end of treatment (Day 14), and 2 and 4 weeks post-treatment. Complete clearance (mycological cure, shown by negative KOH and negative fungal culture, and clinical cure, shown by the absence of pruritus, erythema, and scaling) at 4 weeks post-treatment was the primary efficacy endpoint (P <0.001).

Mild erythema is defined as slight pink coloration; mild scaling is defined as barely perceptible; fine scales present.

Indications and Important Safety Information

Indications

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.

Important Safety Information

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 Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted.
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Reference 1. LUZU [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals.