{"adverse_reactions":["ADVERSE REACTIONS Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria. Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis."],"contraindications":["CONTRAINDICATIONS Nystatin Cream is contraindicated in patients with a history of hypersensitivity to any of its components."],"description":["DESCRIPTION Nystatin Cream is for dermatologic use. Nystatin is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan powder with a cereal-like odor, very soluble in water, and slightly to sparingly soluble in alcohol. Structural formula: Nystatin Cream contains the antifungal antibiotic nystatin at a concentration of 100,000 USP Nystatin Units per gram in an aqueous, perfumed cream base containing purified water, propylene glycol, methylparaben, propylparaben, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum hydroxide gel, titanium dioxide, sorbitol solution, and, if necessary, sodium hydroxide for pH adjustment. image of nystatin structural formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Nystatin Cream should be applied liberally to affected areas twice daily or as indicated until healing is complete. Nystatin Cream is usually preferred to Nystatin Ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with Nystatin Topical Powder."],"effective_time":"20110510","how_supplied":["HOW SUPPLIED Nystatin Cream is a smooth yellow cream with a characteristic perfume odor. Nystatin Cream is providing 100,000 USP Nystatin Units per gram in 15 gram tubes NDC 54868-0242-1 30 gram tubes NDC 54868-0242-0 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: June, 2005 PK-1161-3 262 Relabeling of \"Additional\" label by: Physicians Total Care, Inc. Tulsa, OK 74146"],"how_supplied_table":["<table width=\"30%\" ID=\"ia1946b7d-2871-4f32-813c-7ed4e426645b\"> <tbody> <tr> <td>15 gram tubes  </td> <td>NDC 54868-0242-1  </td> </tr> <tr> <td>30 gram tubes  </td> <td>NDC 54868-0242-0  </td> </tr> </tbody> </table>"],"id":"de53fe32-2a8e-4dd7-bea1-e29b502d8ba8","indications_and_usage":["INDICATIONS AND USAGE Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Nystatin Cream image of package label"],"precautions":["PRECAUTIONS Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken. Nystatin Cream is not for ophthalmic use."],"set_id":"bdb80797-20c8-4fbc-8ef8-b85d6aebdce5","spl_product_data_elements":["NYSTATIN Nystatin NYSTATIN NYSTATIN ALGELDRATE CETEARETH-15 METHYLPARABEN GLYCERYL MONOSTEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM HYDROXIDE SORBITOL TITANIUM DIOXIDE PETROLATUM"],"spl_unclassified_section":["Rx only"],"version":"1"}