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510(k) Data Aggregation

    K Number
    K041342
    Device Name
    IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
    Manufacturer
    STIEFEL LABORATORIES, INC.
    Date Cleared
    2005-07-19

    (425 days)

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

    STIEFEL LABORATORIES, 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, MimyX 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. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Description OTC Product: MimyX Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor burns, including sunburn.
    Device Description
    MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.
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