Label: NYSTATIN cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2025

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  • SPL UNCLASSIFIED SECTION
    For Dermatologic Use Only - Not For Ophthalmic Use - Rx Only
  • DESCRIPTION
    Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula is C47H75NO17, and the molecular weight is 926.13. Structural formula: Nystatin Cream USP is ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics - Nystatin Cream USP is not absorbed from intact skin or mucous membrane. Microbiology - Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a ...
  • INDICATIONS AND USAGE
    Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not ...
  • CONTRAINDICATIONS
    Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.
  • PRECAUTIONS
    General - Nystatin Cream USP 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 USP is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash ...
  • DOSAGE AND ADMINISTRATION
    Very moist lesions are best treated with nystatin topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until ...
  • HOW SUPPLIED
    Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: NDC: 72162-1385-2: 15 g in a TUBE - NDC: 72162-1385-3: 30 g in a TUBE - STORAGE - Store at 20-25°C ...
  • SPL UNCLASSIFIED SECTION
    Manufactured By Padagis - Yeruham, Israel - Distributed By Padagis - Allegan, MI 49010 - www.padagis.com - Rev 12-22 - 68R00 RC J1
  • PRINCIPAL DISPLAY PANEL
    Nystatin 100,000 unit/gram Cream, #15
  • INGREDIENTS AND APPEARANCE
    Product Information