Xyphex Biofrequency Chip Recall
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Questions & Answers
Side Effects & Adverse Reactions
- 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.
- 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.
The safety of Xyphex Biofrequency Chip has not been established during pregnancy.
The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
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.