WARNINGS

Pallerix is a topical dosage form containing 30 medicated biofrequency chips (2 disc-shaped chips on individually wrapped sterile cards X 15 per box of 30). Pallerix (Menthol 5%/Capsaicin 0.0375%) is comprised of an adhesive material containing Menthol and Capsaicin which is applied to a biofrequency chip backing and secured on an application card. Two biofrequency chips are removed from the application card and applied to the skin. The card is discarded after removing the biofrequency chips. The size of each copper colored medicated biofrequency chip is 1.18 X 2.36 inches (3 cm X 6 cm). Menthol is present in a 5% concentration. Menthol is chemically designated as 2-Isopropyl-5-methylcyclohexanol. It is colorless, hexagonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31°C to 36° C. Capsaicin is present in a 0.0375% concentration. Capsaicin is chemically designated as (6E)-N-(4-Hydroxy-3-methoxybenzyl)-8-methyl-6-nonenamide. It is crystalline white powder. It has a melting point of 65° C. It also contains the following inactive ingredients: Polyester-7, Aluminum Acetate, Ethyl Cyanoacrylate, Paraffin, and Propylene Glycol

The disc-shaped biofrequency chip dosage form is programed with bioactive frequencies using longitudinal electromagnetic (scalar) waves that complement the active ingredients menthol and capsaicin.

INDICATIONS AND USAGE

Pallerix medicated biofrequency chip is used to assist patients greater than 12 years in age in the treatment of mild to moderate acute or chronic aches, muscle or joint pain. Two Pallerix biofrequency chips should be administered to the site of discomfort every 12 hours or twice a day. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies or post herpetic neuralgia, and other complex regional pains.

Remain hydrated: The Pallerix biofrequency chip performs optimally when the body is adequately hydrated and contains normal levels of electrolytes such as calcium, sodium, potassium, and magnesium. On average men need 3.7 liters and women need 2.7 liters of fluids per day to remain properly hydrated.

CONTRAINDICATIONS

Known hypersensitivity to menthol, capsaicin, or any of the component of the preparation.

WARNINGS AND PRECAUTIONS

WARNINGS:

Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label.

• Accidental Exposure in Children: the potential exists for a small child or a pet to suffer adverse effects from chewing or ingesting a new or used Pallerix biofrequency chip. It is important for patients to store and dispose of Pallerix biofrequency chips out of the reach of children and pets.
• For external use only.
• Although the Pallerix biofrequency chip contains low frequency waves, it has not been studied with a cardiac pacemaker or defibrillator. Consultation with the attending cardiologist is recommended for patients with implanted electrical devices.
• The Pallerix biofrequency chip should be removed prior to any imaging procedures (e.g. CT scan, MRI, X-ray etc.).
• The Pallerix biofrequency chip should not be used if there are mental or physical conditions that may preclude compliance with physician instructions.

PRECAUTIONS:

• When traveling by air, do not wear the Pallerix biofrequency chip when passing through passenger screening devices or the biofrequency chip could be damaged.
• Application to broken or inflamed skin, although not tested, may result in higher blood concentrations from increased absorption. Pallerix is only recommended for use on intact skin.
• The contact of Pallerix biofrequency chips with eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline.

PREGNANCY:

The safety of Pallerix biofrequency chip has not been established during pregnancy.

ADVERSE REACTIONS:
The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.

OVERDOSAGE:
There have been no reports of over-dosage with Pallerix biofrequency chip. Signs of overdosage could include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

PHARMACODYNAMICS AND METABOLISM

PHARMACODYNAMICS

Menthol works by targeting the k-opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (8° - 28° C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation. Also, because of Menthol's specific targeting of the k-opioid receptor, it is endowed with analgesic properties. Capsaicin is a naturally occurring compound. It is found in chili peppers and is what gives it "heat". Capsaicin has been found to be effective in reducing inflammation and pain. When Capsaicin enters the body it binds with the protein TRPV1 which is located on pain and heat neurons. When the TRPV1 proton is activated (between 37° - 45° C) it opens the calcium ion channel and give the sensation of pain and heat. When Capsaicin binds to the TRPV1 proton it forces the ion channel to open below its normal activation temperature which is why it gives the distinct heating sensation. It is thought that prolonged activation of these neurons by Capsaicin depletes substance P, a neurotransmitter for pain and heat. The end result appears that the nerves are overwhelmed by the influx and unable to report pain for an extended period of time.

METABOLISM
Menthol is rapidly metabolized in human bodies into metabolites such as polyols and hydroxy acids that are subsequently excreted as such or, most predominantly, as glucuronide conjugates. Capsaicin is metabolized extensively by the liver CYP450 enzymes and Carboxyesterase class enzymes and yield numerous byproducts via alkyl, aromatic, and amide metabolic pathways. Due to metabolic changes to the vanilliod ring and Capsaicin's hydrophobic alkyl side chain, the metabolites possess less potential at the VR1 receptor. Capsaicin also possess numerous electrophile metabolites that can bind to liver enzymes and proteins via a reactive arene oxide or quinone methide group.

HOW SUPPLIED

Pallerix biofrequency chip is supplied in the following dosage form:  30 medicated biofrequency chips [(2 per individually wrapped sterile package) x 15]

STORAGE AND HANDLING

Store at room temperature at 68°F to 77°F (20°C to 25° C). Excursion permitted to 59º-86º F (15º -30ºC). [See USP Controlled Room Temperature]. Keep away from heat or sunlight. Protect from excessive moisture. The product may be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

PACKAGE LABEL

Pallerix medicated biofrequency chip package