Nystatin
Nystatin is an FDA drug label for the active ingredient NYSTATIN manufactured by Proficient Rx LP administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231201.
- Generic name
- NYSTATIN
- Manufacturer
- Proficient Rx LP
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 82804-045
- Application
- ANDA212557
- Label effective
- 20231201
Indications & Usage
INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until health is complete.
Contraindications
CONTRAINDICATIONS Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their components.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream 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. )