While zinc is an essential part of the diet, recent publications suggest that an excessive intake of zinc-containing denture adhesives over several years may lead to the development of neurological symptoms. These may include numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and blood problems such as anemia.

Super Poligrip is safe to use as directed in the product label (see below). The majority of consumers follow these directions. However, some consumers apply more adhesive than directed and use it more than once per day. Therefore, as a precautionary measure to minimize any potential risks to these consumers, GSK has voluntarily stopped the manufacture, distribution and advertising of these products. GSK has discussed this situation with the FDA and no further action is required.

What consumers should do
If you have been using zinc-containing Super Poligrip 'Original', 'Ultra Fresh' or 'Extra Care' for several years in greater amounts than directed on the package or more than once per day, or have concerns about your health, you must:

1. Stop using the product.
2. Talk to your doctor.
3. Use a zinc-free alternative such as Super Poligrip 'Free,' Super Poligrip 'Comfort Seal Strips', or Super Poligrip 'Powder'.

People with ill-fitting dentures should seek help from their dental care professional, rather than compensate for poorly fitting dentures by using excessive adhesive.

Polident Denture Cleanser tablets contain no zinc and are not affected by this announcement.

GSK will soon be introducing zinc-free versions of Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care'. Zinc Free Formula will be clearly shown on the new packaging.

Consumers with questions may call GSK toll free on 1-866-640-1017.

For more information on Super Poligrip and zinc, visit http://www.poligrip.com.

Super Poligrip 'Original', 'Ultra Fresh' and 'Extra Care' directions for safe and effective use:

DIRECTIONS: Super Poligrip holds all day. Apply once a day for secure hold. Start with a small amount. Using too much adhesive can cause oozing. If oozing occurs, use less adhesive next time. Do not apply more than once a day. A 2.4 oz tube should last about 8 to 10 weeks. If not, you are using too much adhesive which may be a sign of ill-fitting dentures. See your dentist regularly. Routine dental examinations are part of good oral health and necessary to check the fit of your denture.

APPLYING

1. Clean and dry your dentures.
2. Apply adhesive in two or three short ¼" strips, not too close to denture edges.
3. Rinse mouth before inserting dentures.
4. Press dentures in place, hold firmly, and bite down for a few seconds to secure.
• To keep tip from clogging, keep cap and nozzle dry.

REMOVING

1. Swish mouth with water.
2. Slowly remove dentures by using a rocking motion.
3. Remove denture adhesive residue from denture and mouth with warm water and a soft brush.
4. Use Polident Denture Cleanser to thoroughly clean your denture.

IMPORTANT PRODUCT INFORMATION:

• This product contains zinc. Talk to your doctor before using this product if you are taking daily zinc supplements.
• Do not use if you have sensitivity to any of the cream ingredients. If discomfort occurs discontinue use.
• Swallowing small amounts of this product, when used as directed, may occur and is not harmful.
• Use only as directed. Using excessive amounts of this product over a prolonged period of time has been reported to result in serious health effects from increased zinc intake.

Q1: I have symptoms (i.e. numbness/tingling/weakness), what should I do?
If you are experiencing symptoms please consult a medical professional / your doctor.

Q2: Why has GlaxoSmithKline decided to warn consumers against long term excessive use of zinc-containing denture adhesives?
Consumer health and safety is of utmost importance to GlaxoSmithKline. Because of this, we are issuing an advisory to alert consumers of potential health risks of using excessive amounts of denture adhesives that contain zinc over the long term. Some consumers apply more adhesive than directed and use it more than once per day. Long term, excessive use of zinc-containing denture adhesives has been reported to be associated with certain serious adverse health effects. Therefore, as a precautionary measure to minimize any potential risks to these consumers, GSK has issued this consumer advisory.

Q3: What do you mean by long term excessive use?
Published reports of excessive use have typically described usage of one to two tubes of denture adhesives a week over a period of years. That is in contrast to our label which clearly states that a 2.4 oz tube should last about 8-10 weeks. It is important however that if you are or have been using Super Poligrip 'Original', Super Poligrip 'Ultra Fresh' or Super Poligrip 'Extra Care' in excess of the instructions that you stop using the product and talk to your doctor about any health concerns you might have.
The instructions printed on the packaging illustrate how to use a small amount to avoid oozing, which can occur if too much product is used. There are picture graphics on the box that show you how to apply Super Poligrip and approximately how much should be applied to both the upper and lower dentures.

Application of the product should not be required more than once per day. You should not use more than the indicated quantity of Super Poligrip, or use it more than once per day, to compensate for poorly-fitting dentures. You should consult your dentist regularly to maintain proper-fitting dentures.

As an example of proper use, a tube of Super Poligrip should last several weeks depending on size (e.g., 0.75 oz about 3 weeks, 1.4 oz about 4 to 6 weeks, 2.4 oz about 8 to 10 weeks).

Q4: Is too much zinc harmful to me?
There have been reports of excessive use over the long-term of zinc-containing denture adhesive associated with the development of neurological symptoms, which may include numbness, tingling, or weakness in the limbs, difficulties with walking and balance, and/or the development of blood problems such as anemia.

Q5: I have just seen the product for sale in my local store. Why are you still selling this if it isn't safe?
Super Poligrip is safe when used as directed by the product label. GSK has voluntarily stopped the manufacture, distribution and advertising of these products as a precautionary measure. We have done this to minimize potential risks to those consumers who have used excessive amounts of zinc-containing adhesive over the long term. GSK has discussed this situation with the FDA and no further action is required.

Q6: What are the specific names of the products being taken off shelf?
As a voluntary precautionary measure to minimize potential risks to consumers, the zinc formulations which will no longer be sold are Super Poligrip 'Original', Super Poligrip 'Ultra Fresh', Super Poligrip 'Extra Care'

Q7: I am afraid to use the product and want a refund.
Super Poligrip 'Original', Super Poligrip 'Ultra Fresh', and Super Poligrip 'Extra Care' are safe to use as directed. Consumers with questions may call GSK toll free on 1-866-640-1017.

Q8: Does the zinc-free formulation provide the same level of hold?
The zinc-free formulation provides an effective all-day hold for well-fitted dentures.

Q9: What if I swallowed some adhesive and/or believe I used the product in excess? What are the symptoms of getting too much zinc?
A small amount of adhesive will be swallowed during normal use which isn't harmful. The product is safe when used as directed.

Ingestion of the adhesive at low levels has not been associated with health concerns. Recent reports regarding zinc-containing denture adhesives suggest that excessive use over an extended period of time may result in a zinc-induced copper deficiency which has been associated with the development of blood problems such as anemia, and with disorders of the nervous system, termed myeloneuropothy.

Consumers should ensure they are familiar with directions for appropriate use and should consult their physician with questions.

Q10: How much zinc is in your products?
Super Poligrip contains 38 mg of zinc per gram (i.e., it is less than 4% zinc by weight).

Q11: What is myeloneuropathy?
It is a disorder of the nervous system that can be serious, with symptoms that include numbness or weakness in the limbs, poor balance and difficulty walking.

Q:12: What are the blood problems associated with long-term excessive use of zinc-containing denture adhesives?
These may include reduced numbers of red blood cells, which is called anemia, or reduced numbers of certain white blood cells, which can be called leucopenia or neutropenia.

Q13: I can't find my Super Poligrip on the shelves. When can I buy it?
We are currently in the process of reformulating Super Poligrip 'Original', Super Poligrip 'Ultra Fresh' and Super Poligrip 'Extra Care' to non-zinc formulations. We expect them to be in stores by Mid April 2010. Super Poligrip 'Free', Super Poligrip 'Comfort Seal Strips' and Super Poligrip 'Powder' continues to be available to consumers.

Q14: Should I throw away my zinc-containing Super Poligrip 'Original', Super Poligrip 'Ultra Fresh', Super Poligrip 'Extra Care' product? Is the zinc-containing Poligrip 'Original', Super Poligrip 'Ultra Fresh', Super Poligrip 'Extra Care' in my home safe to use?
Consumers in possession of the zinc-containing formulas of Super Poligrip 'Original', Super Poligrip 'Ultra Fresh', Super Poligrip 'Extra Care' may continue to safely use the product as directed. Consumers should ensure they are familiar with directions for appropriate use.