Label: NYSTATIN AND TRIAMCINOLONE ACETONIDE cream

  • NDC Code(s): 46708-606-15, 46708-606-30, 46708-606-60
  • Packager: Alembic Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 8, 2025

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  • DESCRIPTION
    Nystatin and triamcinolone acetonide cream, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene ...
  • CLINICAL PHARMACOLOGY
    Nystatin - Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the ...
  • CONTRAINDICATIONS
    These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
  • PRECAUTIONS
    General - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and ...
  • ADVERSE REACTIONS
    A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually ...
  • OVERDOSAGE
    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General); however, acute overdosage and serious adverse effects with ...
  • DOSAGE AND ADMINISTRATION
    Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The ...
  • HOW SUPPLIED
    Nystatin and triamcinolone acetonide cream, USP is light yellow to buff color cream supplied as follows: 15 g tube (NDC 46708-606-15) 30 g tube (NDC 46708-606-30) 60 g tube (NDC ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 46708-606-15 - 15 g Tube - Nystatin and Triamcinolone Acetonide Cream USP - FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only - Keep out of reach of children. Alembic ...
  • INGREDIENTS AND APPEARANCE
    Product Information