Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows: NDC 69315-307-15 15 gram tube NDC 69315-307-30 30 gram tube STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-12/17; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton-100000unit15gm Container-100000unit15gm Carton-100000unit30gm Container-100000unit30gm
- HOW SUPPLIED Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows: NDC 69315-307-15 15 gram tube NDC 69315-307-30 30 gram tube STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-12/17
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton-100000unit15gm Container-100000unit15gm Carton-100000unit30gm Container-100000unit30gm
Overview
Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 Nystatin Ointment is for dermatologic use. Nystatin Ointment for topical use contains 100,000 USP nystatin units per gram in a polyethylene and mineral oil base. Chemical-structure
Indications & Usage
Nystatin topical powder 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
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 ). CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.
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