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510(k) Data Aggregation

    K Number
    K190342
    Device Name
    BIAFINE Topical Cream
    Date Cleared
    2019-10-18

    (246 days)

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

    Bausch Health Americas Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.
    Device Description
    BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients include Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.
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