Active against strains of tinea-causing organisms

OXISTAT Lotion is an imidazole antifungal¹:

Proven active against most strains of the following organisms¹:
- Clinical and in vitro: Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum
- In vitro*: Candida albicans, Microsporum audouini, Microsporum canis, Microsporum gypseum, Trichophyton tonsurans, and Trichophyton violaceum (the clinical significance is unknown)

OXISTAT Lotion is fungistatic and, under certain conditions, has been shown to be fungicidal²

* The safety and efficacy of oxiconazole in treating clinical infections due to these organisms have not been established in adequate and well-controlled clinical trials.¹

References: 1. OXISTAT Lotion Prescribing Information; July 2022. 2. Data on file, ANI Pharmaceuticals, Inc.

Important Safety Information

For topical dermatologic use only. Not for oral, ophthalmic, or intravaginal use.

OXISTAT^® (oxiconazole nitrate) Lotion is contraindicated in individuals who have shown hypersensitivity to any of its components. If a reaction suggesting sensitivity or chemical irritation should occur with the use of OXISTAT Lotion, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.

In a clinical trial with OXISTAT Lotion (N=269), the most common adverse events were burning and stinging (0.7% each) and pruritus, scaling, tingling, pain and dyshidrotic eczema (0.4% each).

The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, erythema, papules, fissure, maceration, rash, and nodules.

You are encouraged to report negative side effects of prescription drugs to the FDA. Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.

Click here to see full Prescribing Information.

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OXISTAT^® is a registered trademark of Fougera Pharmaceuticals, Inc.
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10470 Rev 03/23