Label: KETOCONAZOLE cream

  • NDC Code(s): 51672-1298-1, 51672-1298-2, 51672-1298-3
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 9, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol ...
  • CLINICAL PHARMACOLOGY
    When ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method ...
  • INDICATIONS AND USAGE
    Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by - Trichophyton rubrum, T. mentagrophytesand - Epidermophyton ...
  • CONTRAINDICATIONS
    Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
  • WARNINGS
    Ketoconazole cream, 2% is not for ophthalmic use.
  • PRECAUTIONS
    General - If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses ...
  • ADVERSE REACTIONS
    During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation ...
  • DOSAGE AND ADMINISTRATION
    Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor - It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and ...
  • HOW SUPPLIED
    Ketoconazole cream, 2% is supplied in 15 g (NDC 51672-1298-1), 30 g (NDC 51672-1298-2), and 60 g (NDC 51672-1298-3) tubes. Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature] ...
  • SPL UNCLASSIFIED SECTION
    Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 - Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 - Revised: March, 2014 - PK-2925-4 - 354
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
    NDC 51672-1298-1 - 15 g - Ketoconazole - Cream 2% FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx only - Keep this and all medications out of the reach of ...
  • INGREDIENTS AND APPEARANCE
    Product Information