Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052643
    Device Name
    EPICERAM
    Manufacturer
    CERAGENIX CORPORATION
    Date Cleared
    2006-04-11

    (197 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAGENIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR TOPICAL DERMATOLOGICAL USE ONLY EPICERAM® is a skin barrier emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, radiation dermatitis. EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.
    Device Description
    EPICERAM™ is a non-sterile, viscous, lipid-rich emulsion presented for prescription use.
    Ask a Question

    Page 1 of 1