Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083721
    Device Name
    MODIFICATION TO ZENIEVA
    Manufacturer
    RIVER'S EDGE PHARMACEUTICALS, LLC
    Date Cleared
    2009-01-08

    (24 days)

    Product Code
    NAE
    Regulation Number
    878.4022
    Why did this record match?
    Applicant Name (Manufacturer) :

    RIVER'S EDGE PHARMACEUTICALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
    Ask a Question

    Page 1 of 1