Label: NYSTATIN ointment

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei.

Structural formula:

Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum.

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

General

Nystatin ointment should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Patients using these medications should receive the following information and instructions:

1.  The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.

2.  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.

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

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.)

Nystatin Ointment

Adults and Pediatric Patients (Neonates and Older):

Apply liberally to affected areas twice daily or as indicated until healing is complete.

Nystatin ointment USP, 100,000 units per gram is a pale yellow to yellow color ointment available as follows:

NDC 13668-534-01 15 gram tube

NDC 13668-534-02 30 gram tube

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Pithampur-454775, INDIA .

Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920

8063926                                                                                                       Revised June 2018

Nystatin Ointment, USP 15 grams (Tube label)

Nystatin Ointment, USP 15 grams (Carton label)

Nystatin Ointment, USP 30 grams (Tube label)

Nystatin Ointment, USP 30 grams (carton label)