Please read this information carefully because it contains directions on the safe use of Dr. Theiss Alergol Pollen Blocker Cream. If you have any questions, ask your general practitioner.

Description: Dr. Theiss 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. It does not penetrate the skin and is not absorbed. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied.

Intended Use: Dr. Theiss Alergol Pollen Blocker Cream is intended to promote alleviation of mild allergic rhinitis 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. Reduction of allergen levels is accomplished by means of a layer of ointment applied to both nostrils, which traps airborne particles as they enter the nose.

Dr. Theiss Alergol Pollen Blocker cream is intended for topical use and provided nonsterile. Dr. Theiss Alergol Pollen Blocker Cream (5 grams nasal ointment) contains no preservatives, no scented chemicals, and no other substances are present.

Directions for Use: Dr. Theiss Alergol Pollen Blocker Cream is applied to the front nasal vestibule area. Take a strand of ointment approximately 1/4 – 1/2 inch long for each side of the nose and rub it evenly into the nostril, at the entrance of the nose, using a cotton swab or a finger. This coats the inside wall of the nose with a thin protective layer intended to block inhaled allergy carriers (e. g. flower, tree and grass pollen, house dust, house dust mites, and animal hair).

It is important to apply the cream evenly. Excessive application is unnecessary and will not improve the effect of the product. If you use too much of the ointment unintentionally in an application, any excess will be removed by the natural cleaning mechanisms of the nose and throat (e.g. cilia, swallowing reflex). Once you have applied the ointment, breathe normally through your nose.

Duration of Use: In general, the effect of the protective layer lasts for 3 to 5 hours. The ointment can also be applied at shorter intervals as necessary.
Dr. Theiss Alergol Pollen Blocker Cream can be used seasonally or for longer periods of time. In the case of pollen allergy, use should be limited to hay fever season. For longer-term use, e. g. in treating allergies due to house dust, mites, or contact with domestic animals, ask your doctor for appropriate medical advice.

Contraindications – When not to use this product: Like all nasal ointments and creams, Dr. Theiss Alergol Pollen Blocker cream should not be used by patients who suffer from dysphasia, a disturbance of the swallowing reflex. A noticeable sign of dysphagia is frequent choking on food or liquids. Do not apply Dr. Theiss Alergol Pollen Blocker Cream to open wounds in the nose,
since this can alter the natural wound healing process. Due to the preparation’s physical mode of action and its topical administration, there
are no known interactions with other medicines. Dr. Theiss Alergol Pollen Blocker Cream can therefore be safely combined with other forms of allergy treatments.

Precautions: Before each application, you should clean your nose by removing any adherent particles using a saline nasal spray. Studies on the use of this product at night are unavailable. Therefore, it is not recommended to use the ointment while asleep during the night. Keep Dr. Theiss Alergol Pollen Blocker Cream out of reach of children.

Adverse Reactions: There have been no reports of any adverse effects with the use of such products for topical purposes, even in the nasal cavity.
There have been no reports of habituation, dose tolerance, or sensitization with this product when used in a manner consistent with these instructions for use. In rare cases, especially with oily and profusely sweating skin, the ointment's sealing effect can cause reversible non-specific irritation reactions (reddening). There is no evidence that this reaction is medically significant and it should not have any damaging effects on your health. If you notice side effects that are not listed in this package insert, or if your symptoms become worse, stop using this product and consult your doctor.

Laboratory and Testing: Appropriate toxicology and pharmacology testing
demonstrates that Dr. Theiss Alergol Pollen Blocker is safe for topical use as
described in the product labeling. The biocompatibility of Dr. Theiss Alergol Pollen Blocker Cream is consistent with the results of the toxicology and safety performance testing. Dr. Theiss Alergol Pollen Blocker does not contain any materials that are subject to the risk of transmission of bovine spongiform encephalitis (BSE). Stability and packaging materials testing demonstrate that the product has a shelf life of over 5 years at room temperature.

Results from Clinical Trials: The safety and effectiveness of Dr. Theiss Alergol Pollen Blocker Cream has been demonstrated in a clinical study: a multi-center, prospective, randomized, double-blind, placebo-controlled crossover study (N=91) of the anti-allergic effectiveness of Dr. Theiss Alergol Pollen Blocker nasal cream in treating patients suffering from allergic rhinitis. This study demonstrated the safety and effectiveness of Dr. Theiss Alergol Pollen Blocker Cream. Symptom scores decreased significantly for patients treated with Dr. Theiss Alergol Pollen Blocker Cream by up to 40% (p = 0.001) and nasal airflow resistance went down by approximately 50%. Treated patients reported that the blocker cream was well- tolerated and no side-effects occurred as a result of application of the nasal cream.
The methylcellulose control also provided treatment and is not a true placebo, but a comparator product. However, the treatment effect for patients treated with Dr. Theiss Alergol Pollen Blocker Cream was statistically more significant than for those treated with the control therapy.
More specifically, in the clinical investigation (S. Schwetz et al. Arch Otolaryngol Head Neck Surgery. 2004;130:979-984) Dr. Theiss Alergol Pollen Blocker Cream was found to be effective for the prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis.
In this double-blind, randomized, placebo-controlled, crossover study, ninety-one patients were randomly assigned to receive pollen blocker cream (n=43) or carboxymethylcellulose gel (placebo) (n=48). The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range 0-6) and the
changes in nasal airflow after allergen challenge.

Results: Dr. Theiss Alergol Pollen Blocker Cream was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25%*).

The increase in airflow in response to treatment was approximately 20% in the Pollen Blocker Cream group compared to 10% in the placebo group.
Patient results can be categorized as follows:

Approximately 50% of patients were therefore high responders, 25% were
responders, and 25% were non-responders. Dr. Theiss Alergol Pollen Blocker Cream did not produce any adverse effects.

Product Storage: Stability and packaging materials testing demonstrate that the product has a shelf-life of over 5 years at room temperature. The Pollen Blocker Cream is intended for topical use and provided non-sterile.
The 'Use by' date for this package is printed on the side of the folding box and on the end of the tube fold. You should not use the contents of the product after this date.

Pending US Patent Application No. 10/296, 934
Distributed by:
Pronatura Inc., 878 Sivert Drive, Wood Dale, IL 60191, USA
Phone: +1-630 766 3810; toll-free within the U.S. 800 555 7580,
Fax: +1 630 766 3850, http://www.pronaturainc.com
Manufactured by:
Dr. Theiss Naturwaren GmbH, PO Box 1559, Homburg, 66424, Germany
http://www.alergol.com, Phone: +49 6841 7090, Fax: +49 6841 709 212