DESCRIPTION - FOR PROFESSIONAL USE ONLY, DISPENSED BY PRESCRIPTION

Xyphex Biofrequency Chip is a topical dosage form containing 30 medicated biofrequency chips (2 disc-shaped chips on individually wrapped cards X 15 per box of 30). Xyphex Biofrequency Chip (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 diameter of each disc-shaped medicated biofrequency chip is .91 inches (2.3 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

Xyphex Biofrequency Chip is a topical formulation used under medical supervision to assist patients greater than 12 years in age in the management of mild to moderate, acute or chronic migraine headache. Xyphex Biofrequency Chip can also be used for the temporary relief of minor aches and muscle pains. Xyphex Biofrequency Chip should be administered as directed every 12 hours. Typical application of two biofrequency chip is to the right and left temple area or both on the base of the neck. Use with caution when applying in order to avoid eye contact.

Remain hydrated: The Xyphex Biofrequency Chip performs optimally when the body is adequately hydrated and contains normal levels of electrolytes such as calcium, sodium, potassium, and magnesium. 

PURPOSE

Xyphex Biofrequency Chip purpose is to aid in the management of acute or chronic migraine headaches.

KEEP OUT OF REACH OF CHILDREN

Xyphex Biofrequency Chip should be stored out of the reach of children.

WARNINGS

• 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 Xyphex Biofrequency Chips. It is important for patients to store and dispose of Xyphex Biofrequency Chip out of the reach of children and pets.
• For external use only.
• Although the Xyphex 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 Xyphex Biofrequency Chip should be removed prior to any imaging procedures (e.g. CT scan, MRI, X-ray etc.).
• The Xyphex 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 Xyphex 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. Xyphex Biofrequency Chip is only recommended for use on intact skin.
• The contact of Xyphex Biofrequency Chip 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 Xyphex 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.

OVER DOSAGE:
There have been no reports of over dosage with Xyphex Biofrequency Chip. Signs of over dosage could include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an over dosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

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 gives 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 yields 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.

DOSAGE & ADMINISTRATION

DISPENSED BY PRESCRIPTION

Xyphex Biofrequency Chip is supplied as the following: 30 medicated biofrequency chips with 5.0% menthol and 0.0375% capsaicin [(2 per individually wrapped package) x 15] and manufactured under cGMP conditions (Current Good Manufacturing Practices).

Apply 2 Xyphex Biofrequency Chips to the affected area of intact skin.

1. Clean and dry affected area. Shaving excess hair may help adhesion of biofrequency chip.
2. Open pouch and remove one Migryl Biofrequency Chips card that contains 2 biofrequency chips.
3. Remove two medicated biofrequency chips from the card and apply sticky side directly to area of pain.
4. Apply two medicated biofrequency chips to affected area two (2) times daily or every 12 hours.
5. Wash hands with soap after applying Xyphex Biofrequency Chips.
6. Reseal pouch containing unused Xyphex Biofrequency Chips. Once the sterile packaging is opened, utilize both biofrequency chips. Do not store unused Xyphex Biofrequency Chips outside the packaging or in an opened package.
7. Fold used Migryl Biofrequency Chips so that the adhesive side sticks to itself and safely discard used Xyphex Biofrequency Chips where children and pets cannot get to them.

ACTIVE INGREDIENTS

5.0% menthol; 0.0375% capsaicin

INACTIVE INGREDIENTS

Polyester-7, Aluminum Acetate, Ethyl Cyanoacrylate, Paraffin, and Propylene Glycol

STORAGE AND HANDLING

Store at room temperature at 68°F to 77°F (20°C to 25° C). Excursion permitted to 59°-86° F (15° -30°C). [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

Xyphex Biofrequency Chip packaging.