Nystatin
Generic: NYSTATIN
Basic Information
Manufacturer
Macleods Pharmaceuticals Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
Indications & Usage
INDICATIONS AND USAGE Nystatin Ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Adverse Reactions
ADVERSE REACTIONS 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 Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).
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 Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).