Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15 g (NDC 68382-370-01) 30 g (NDC 68382-370-02) 60 g (NDC 68382-370-03) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-01 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS Zydus 15 g Bottle Label 15 g Bottle Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-02 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 30 GRAMS Zydus 30 g Bottle Label 30 g Bottle Label; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-03 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 60 GRAMS Zydus 60 g Bottle Label 60 g Bottle Label
- HOW SUPPLIED Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15 g (NDC 68382-370-01) 30 g (NDC 68382-370-02) 60 g (NDC 68382-370-03) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-01 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 15 GRAMS Zydus 15 g Bottle Label 15 g Bottle Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-02 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 30 GRAMS Zydus 30 g Bottle Label 30 g Bottle Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-370-03 Nystatin Topical Powder, USP FOR TOPICAL USE ONLY 100,000 units per gram Rx Only 60 GRAMS Zydus 60 g Bottle Label 60 g Bottle Label
Overview
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. 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 topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage & Administration
Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infections of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.
Warnings & Precautions
No warnings available yet.
Contraindications
Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse Reactions
The frequency of adverse events reported in patients using nystatin topical powder 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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