Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED KLAYESTA (nystatin topical powder, USP) is off-white to light yellow powder, and is supplied as 100,000 units nystatin per gram in plastic squeeze bottles. 15 g (NDC 42806-186-15) 30 g (NDC 42806-186-30) 60 g (NDC 42806-186-60); PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 15 grams klayesta-15g; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 30 grams klayesta-30g; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 grams klayesta-60g
- HOW SUPPLIED KLAYESTA (nystatin topical powder, USP) is off-white to light yellow powder, and is supplied as 100,000 units nystatin per gram in plastic squeeze bottles. 15 g (NDC 42806-186-15) 30 g (NDC 42806-186-30) 60 g (NDC 42806-186-60)
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 15 grams klayesta-15g
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 30 grams klayesta-30g
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 grams klayesta-60g
Overview
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structural-formula.jpg
Indications & Usage
KLAYESTA is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. KLAYESTA 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 infection 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
KLAYESTA 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 KLAYESTA 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 .)
Storage & Handling
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. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 06-2025-00 MF186REV06/25 OS0017
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