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510(k) Data Aggregation

    K Number
    K143605
    Device Name
    Nutraseb Facial Cream
    Manufacturer
    Date Cleared
    2016-04-14

    (482 days)

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

    ISDIN Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, NUTRASEB Facial Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. NUTRASEB Facial Cream helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    NUTRASEB Facial Cream is a non-sterile, steroid-free, fragrance-free, water-based emulsion for the management of the signs and symptoms of seborrheic dermatitis which is presented for prescription use. NUTRASEB Facial cream is supplied in a polyethylene tube. Two 50 gram polyethylene tubes will be packaged together within a single carton.
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