Nystatin Cream

Nystatin Cream, USP is a smooth yellow cream.

Nystatin Cream, USP is supplied in 15 g (NDC 0713-0678-15) and 30 g (NDC 0713-0678-31) tubes providing 100,000 USP Nystatin units per gram.

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

Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. Revised: Aug 2015

Please refer to the PRECAUTIONS section.

No information provided.

Patients using this medication should receive the following information and instructions:

The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.

Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.

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

Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows:

15 g tube (NDC 45802-059-35)

30 g tube (NDC 45802-059-11)

Storage

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

Manufactured By Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010 • www.perrigo.com

Rev. 07-15

: 1P600 RC JX1