Label: CICLOPIROX OLAMINE cream

  • NDC Code(s): 68462-297-17, 68462-297-35, 68462-297-92
  • Packager: Glenmark Pharmaceuticals Inc., USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2019

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  • SPL UNCLASSIFIED SECTION
    FOR DERMATOLOGIC USE ONLY. NOT FOR USE IN EYES. Rx Only
  • DESCRIPTION
    Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the metal-dependent enzymes that ...
  • INDICATIONS AND USAGE
    Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton ...
  • CONTRAINDICATIONS
    Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
  • WARNINGS
    Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.
  • PRECAUTIONS
    If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, treatment should be discontinued and appropriate therapy ...
  • ADVERSE REACTIONS
    In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus ...
  • DOSAGE AND ADMINISTRATION
    Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms ...
  • HOW SUPPLIED
    Ciclopirox olamine cream USP, 0.77% is supplied in 15 grams (NDC 68462-297-17), 30 grams (NDC 68462-297-35) and 90 grams (NDC 68462-297-92) tubes.
  • STORAGE AND HANDLING
    Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India - Manufactured for: Glenmark Pharmaceuticals Inc., USA - Mahwah, NJ 07430 - Questions? 1 (888 ...
  • Principle Display Panel
    NDC 68462-297-35 - Ciclopirox Olamine Cream USP, 0.77% For dermatologic use only. Not for use in eyes.
  • INGREDIENTS AND APPEARANCE
    Product Information