Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113807
    Device Name
    DEXERYL CREAM
    Date Cleared
    2012-03-07

    (75 days)

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

    PIERRE FABRE MEDICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DEXERYL™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYL™ Cream provides a moist environment, which is beneficial to the healing process.
    Device Description
    DEXERYLTM Cream is a clean but non-sterile skin emollient designed to provide protection and a moist environment to the skin, which is beneficial to the healing process. DEXER YL™ Cream is an oil in water emulsion, consisting of >50% water with glycerin, white soft paraffin, liquid paraffin, and other common excipients. The device formulation therefore confers an emollient effect, softening and soothing the skin to help prevent dry skin, irritation and itching. DEXER YL™ Cream is a prescription device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1