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510(k) Data Aggregation

    K Number
    K082089
    Device Name
    PRUMYX CREAM
    Manufacturer
    PRUGEN, INC.
    Date Cleared
    2009-01-13

    (173 days)

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

    PRUGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, PruMyx Cream is indicated to manage and relieve the burning and itching experienced with various-types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. PruMyx Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Description OTC Product: PruMyx Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. PruMyx Cream may also be used to soothe minor bums, including sunburn.
    Device Description
    PruMyx™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.
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