Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystop ® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. (NDC 0574-2008-15) (NDC 0574-2008-30) (NDC 0574-2008-02) STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4; PRINCIPAL DISPLAY PANEL NDC 0574-2008-15 Rx Only NYSTOP ® Nystatin Topical Powder, USP 100,000 USP Units Per Gram USUAL DOSAGE: Apply to affected area 2 or 3 times daily. STORAGE: Store at controlled room temperature 15° - 30°C (59° - 86°); avoid excessive heat (40°C; 104°F). Net Weight 15 grams The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Nystop, Nystatin Topical Powder label image serialization-template
- HOW SUPPLIED Nystop ® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. (NDC 0574-2008-15) (NDC 0574-2008-30) (NDC 0574-2008-02) STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4
- PRINCIPAL DISPLAY PANEL NDC 0574-2008-15 Rx Only NYSTOP ® Nystatin Topical Powder, USP 100,000 USP Units Per Gram USUAL DOSAGE: Apply to affected area 2 or 3 times daily. STORAGE: Store at controlled room temperature 15° - 30°C (59° - 86°); avoid excessive heat (40°C; 104°F). Net Weight 15 grams The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Nystop, Nystatin Topical Powder label image serialization-template
Overview
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc. Structural Formula
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. This preparation 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
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 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 .)
Storage & Handling
STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4
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