Label: ALZAIR- cream, nasal, topical, mechanical allergen particle barrier

  • Category: MEDICAL DEVICE

Drug Label Information

Updated April 2, 2018

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  • Description

    Alzair™ is a clinically proven, unique, natural product that works with the body's own nasal defense mechanism to strengthen its resistance to airborne allergens, such as pollen, dust mites, pet dander, and mold, which are inhaled through the nose. Alzair™ is a natural plant-based extract that meets the highest purity and safety standards.

    Studies have shown that by naturally enhancing nasal mucus, it is possible to filter out airborn allergens.  Alzair™ works by forming  colorless, mucus-like gel lining in the nasal tract that acts as a barrier against pollen, dust, animal dander and mold.

    Rx Only

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  • Indications and Usage

    Alzair™ Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborn allergens including indoor and outdoor environmental pollens, house dust, animal hairs and dust mites.

    Application of Alzair™ produces a mucus-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

    Who can use Alzair™:

    Alzair™ is suitable for adults, including pregnant or breastfeeding women, and for pediatrics*.

    Ingredients:

    Hydroxypropyl methylcellulose, mint scent

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  • Warnings and Precautions:

    Discontinue use if irritation develops.

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  • Dosage & Administration:

    Before first use, test the pressure needed to administer an ideal dose. To do this, shake the bottle and remove the cap. Aim the bottle away from yourself and squeeze the bottle into the air.

    - For pediatric patients, squeeze gently for a 2-inch plume

    - For patients 12 years and up, squeeze firmly for a 6-inch plume.

    Shake bottle before each use.

    Squeeze the bottle away from yourself. Test the pressure needed to administer an ideal dose, which is approximately a two-inch to six inch plume of powder (see above)
    Gently blow your nose. Breath out.
    Place a finger over one nostril to close it.
    Place the Alzair™ bottle nozzle in the other nostril
    Quickly and firmly push the sides of the bottle together to deliver one "puff" of Alzair™ powder while gently inhaling.
    Wait two seconds and then gently inhale to enable the Alzair™ powder to penetrate into the nasal passages. Repeat steps 3-6 on the other nostril.

    Alzair™ may be used as often as required but is recommended three times a day (minimum). The key to getting the best out of Alzair™ is to make sure you maintain a constant layer of powder across the inner lining of your nose. Doing this creates the barrier between the aggravating allergens and sensitive membrane within the nasal tract.

    Take Alzair™ before entering an environment containing airborne allergens- e.g. going out to the garden or dusting.

    Remember to reapply each time you blow your nose.

    * Based on the results of a clinical trial reported in Pediatric Allergy and Immunology [22 (2011); 594-599] of patients 8-18 years old with seasonal allergic rhinitis who were successfully treated with Alzair™.

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  • How Alzair™ is Supplied

    800 mg of Alzair™ powder is supplied in a proprietary squeeze bottle.  It is packaged with an insert (shown below) in a box.

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  • Manufacturer:

    Alzair™ is manufactured for

    Hudson Scientific LLC
    103 W. Main St.
    Hudson, MI  49247

    Rx Only

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  • Alzair™ Bottle Label:

    The Alzair™ bottle label is pictured below:

    image description
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  • Alzair™ Insert

    The insert below is included in each box of Alzair™:

    image description
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  • Alzair™ Box

    Each Alzair™ bottle is sold in the box pictured below:

    Alzair Box
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  • INGREDIENTS AND APPEARANCE
    ALZAIR 
    cream, nasal, topical, mechanical allergen particle barrier
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:70914-030
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:70914-030-01 1 in 1 BOX
    1 800 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K170848 01/01/2018
    Labeler - Hudson Scientific LLC (080339637)
    Establishment
    Name Address ID/FEI Business Operations
    Hudson Scientific LLC 080339637 repack
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