Nystop

INDICATIONS AND USAGE Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

CONTRAINDICATIONS Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General .)

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc. Structural Formula

HOW SUPPLIED Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. NDC: 72162-1124-2: 15 g in a BOTTLE NDC: 72162-1124-3: 30 g in a BOTTLE NDC: 72162-1124-6: 60 g in a BOTTLE STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504