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510(k) Data Aggregation

    K Number
    K173549
    Device Name
    BIAFINE
    Manufacturer
    Valeant Pharmaceuticals
    Date Cleared
    2018-08-13

    (270 days)

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

    Valeant Pharmaceuticals

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, 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: 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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