Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 Image; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 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) Tube Label of 15 g Carton Label of 15 g Tube Label 30 g Carton Label 30 g
- HOW SUPPLIED 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 Image
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 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) Tube Label of 15 g Carton Label of 15 g Tube Label 30 g Carton Label 30 g
Overview
Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol 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. Image
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
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. )
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