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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  • DESCRIPTION
    Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics - 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 ...
  • INDICATIONS AND USAGE
    Nystatin 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 ...
  • CONTRAINDICATIONS
    Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
  • PRECAUTIONS
    General - Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be ...
  • ADVERSE REACTIONS
    The 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 ...
  • DOSAGE AND ADMINISTRATION
    Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.
  • HOW SUPPLIED
    Nystatin Cream USP is yellow to light green smooth cream and supplied as follows:                                 Tube of 15 g                                            NDC ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label
    NDC 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 ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label
    NDC 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information