PALLERIX OTC BIOFREQUENCY CHIP- menthol and capsaicin disc 
BASIEM

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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INDICATIONS AND USAGE

Pallerix OTC  medicated BIOfrequency chip is used to assist patients greater than 12 years in age in the treatment of mild acute or chronic aches, muscle or joint pain. Two Pallerix BIOfrequency Chips should be administered to the site of discomfort and replaced as needed. 

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Pallerix OTC BIOfrequency chip should be stored out of the reach of children.

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

HOW SUPPLIED

Pallerix OTC BIOfrequency chip is supplied in the following dosage form:  30 medicated biofrequency chips containing 2.5% menthol and 0.0018% capsaicin  [(2 per individually wrapped sterile package) x 15].

Apply 2 Pallerix OTC 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 Pallerix OTC BIOfrequency chip card that contains 2 biofrequency chips.
  3. Remove two 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 Pallerix OTC BIOfrequency chips.
  6. Reseal pouch containing unused Pallerix OTC BIOfrequency chips. Once the sterile packaging is opened, utilize both biofrequency chips. Do not store unused Pallerix OTC BIOfrequency chips outside the sterile packaging or an opened package.
  7. Fold used Pallerix OTC BIOfrequency chips so that the adhesive side sticks to itself and safely discard used Pallerix OTC 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

2.5% menthol; 0.0018% capsaicin

INACTIVE INGREDIENTS

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

PACKAGE LABEL

Pallerix OTC BIOfrequency Chip package

image description

PALLERIX OTC BIOFREQUENCY CHIP 
menthol and capsaicin disc
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69597-221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.001875 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5   in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYESTER-7 (UNII: 0841698D2F)  
ALUMINUM ACETATE (UNII: 80EHD8I43D)  
ETHYL CYANOACRYLATE (UNII: 2G95FOH7SF)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69597-221-30100 g in 1 PACKAGE; Type 0: Not a Combination Product04/10/201508/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/10/201508/01/2016
Labeler - BASIEM (079686680)
Establishment
NameAddressID/FEIBusiness Operations
BASIEM079686680label(69597-221)

Revised: 11/2016
 
BASIEM