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510(k) Data Aggregation

    K Number
    K042610
    Device Name
    DR. THEISS ALERGOL POLLEN BLOCKER CREAM
    Manufacturer
    DR. THEISS NATURWAREN GMBH
    Date Cleared
    2005-05-16

    (234 days)

    Product Code
    NUP
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. THEISS NATURWAREN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alergol Pollen Blocker Cream is intended to promote alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs, and dust mites.
    Device Description
    Alergol Pollen Blocker Cream is a viscous topical nasal cream consisting of highly refined aliphatic long-chain hydrocarbons for prophylaxis and therapy of allergic rhinitis caused by airborne allergens. The product is applied by finger or cotton swab to the inside surface of the nasal vestibule in the region of the nose flap where it acts as a mechanical barrier to reduce the adverse effects of inhaled allergens. Proper application of the cream makes it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reduces the intensity of allergic rhinitis symptoms. The hydrocarbon gel is chemically inert to the body and nasal membranes, and contains no additives. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied. The Alergol Pollen Blocker cream is intended for topical use and provided non-sterile.
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