Alzair by Hudson Scientific LLC ALZAIR-

Alzair by

Drug Labeling and Warnings

Alzair by is a Other medication manufactured, distributed, or labeled by Hudson Scientific LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Warnings and Precautions:

Discontinue use if irritation develops.

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™.

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.

Manufacturer:

Alzair™ is manufactured for

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

Rx Only

Alzair™ Bottle Label:

The Alzair™ bottle label is pictured below:

Alzair Insert

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

Alzair™ Box

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

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