DESCRIPTION - FOR PROFESSIONAL USE ONLY, DISPENSED BY PRESCRIPTION

Nexalgia is a topical dosage form containing 30 medicated biofrequency chips (2 disc-shaped chips on individually wrapped cards X 15 per box of 30). Nexalgia 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 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

Nexalgia 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 Nexalgia biofrequency chips should be administered to the site of discomfort every 12 hours or twice a day.

Remain hydrated: The Nexalgia 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.

PURPOSE

Nexalgia biofrequency chip purpose is to aid in the management of acute or chronic aches and pains.

CONTRAINDICATIONS

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

KEEP OUT OF REACH OF CHILDREN

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

DISPENSED BY PRESCRIPTION

Nexalgia biofrequency chip is supplied in the following dosage form:  30 medicated biofrequency chips containing 5.0% menthol and 0.0375% capsaicin  [(2 per individually wrapped sterile package) x 15].

Apply 2 Nexalgia 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 Nexalgia biofrequency chip 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 Nexalgia biofrequency chips.
6. Reseal pouch containing unused Nexalgia biofrequency chips. Once the sterile packaging is opened, utilize both biofrequency chips. Do not store unused Nexalgia biofrequency chips outside the sterile packaging or an opened package.
7. Fold used Nexalgia biofrequency chips so that the adhesive side sticks to itself and safely discard used Nexalgia biofrequency chips where children and pets cannot get to them.

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.

ACTIVE INGREDIENTS

5.0% menthol; 0.0375% capsaicin

INACTIVE INGREDIENTS

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

PACKAGE LABEL

Nexalgia medicated biofrequency chip package