Label: NYSTATIN cream
- NDC Code(s): 59651-907-14, 59651-907-30
- Packager: Aurobindo Pharma Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 26, 2025
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- Official Label (Printer Friendly)
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DESCRIPTIONNystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula ...
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CLINICAL PHARMACOLOGYPharmacokinetics - Nystatin is not absorbed from intact skin or mucous membrane. Microbiology - Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide ...
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INDICATIONS AND USAGENystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for ...
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CONTRAINDICATIONSNystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
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PRECAUTIONSGeneral - Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be ...
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ADVERSE REACTIONSThe frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema ...
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DOSAGE AND ADMINISTRATIONAdults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.
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HOW SUPPLIEDNystatin Cream USP is yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube LabelNDC 59651-907-14 - Rx only - Nystatin Cream, USP - 100,000 units per gram - FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton LabelNDC 59651-907-14 - Rx only - Nystatin Cream, USP - 100,000 units per gram - FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all ...
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INGREDIENTS AND APPEARANCEProduct Information