Nystatin

Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candidaalbicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.

Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.

The frequency of adverse events reported in patients using Nystatin Ointment 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. ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .