Get your patient on Nystatin Cream - Nystatin Cream cream (Nystatin Cream)

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.

Adults and Pediatric Patients (Neonates and Older)
Apply liberally to affected areas twice daily or as indicated until healing is complete.

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

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 .)

To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

C ₄₇ H ₇₅ NO ₁₇ Molecular Weight: 926.13

Nystatin cream is for dermatologic use.

Each gram contains 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate.

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Nystatin Cream USP is a light yellow to yellow cream that is supplied in:
15 gram tube NDC 0316-0221-15
30 gram tube NDC 0316-0221-30

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Manufactured and Distributed by:
Crown Laboratories, Inc., Johnson City, TN 37604

Printed in USA

P9526.00