Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellowish ointment available as follows: NDC 33342-481-15 15 gram tube NDC 33342-481-30 30 gram tube Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 01/2021; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Tube NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Carton NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Tube NDC 33342-481-30 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Carton NDC 33342-481-30 nystatin-tube-15-gm nystatin-carton-15-gm nystatin-tube-30-gm nystatin-carton-30-gm
- HOW SUPPLIED Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellowish ointment available as follows: NDC 33342-481-15 15 gram tube NDC 33342-481-30 30 gram tube Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 01/2021
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Tube NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Carton NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Tube NDC 33342-481-30 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Carton NDC 33342-481-30 nystatin-tube-15-gm nystatin-carton-15-gm nystatin-tube-30-gm nystatin-carton-30-gm
Overview
Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 structure.jpg
Indications & 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.
Dosage & Administration
DOSAGE & ADMINISTRATION Nystatin Ointment Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Warnings & Precautions
No warnings available yet.
Contraindications
Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
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 ).
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