- FOR PROFESSIONAL USE ONLY, DISPENSED BY PRESCRIPTION Colliginix
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Colliginix BIOfrequency chip is supplied in the following dosage form: 15 medicated BIOfrequency chip bandages [ (1 per individually wrapped card) x 15 ] 69597-103-15; PACKAGE LABEL image description
- HOW SUPPLIED Colliginix BIOfrequency chip is supplied in the following dosage form: 15 medicated BIOfrequency chip bandages [ (1 per individually wrapped card) x 15 ] 69597-103-15
- PACKAGE LABEL image description
Overview
- FOR PROFESSIONAL USE ONLY, DISPENSED BY PRESCRIPTION Colliginix is a prescription topical BIOfrequency chip containing 15 medicated BIOfrequency chip bandages (1 BIOfrequency chip in an individually wrapped package X 15 per box of 30). Colliginix is comprised of an adhesive material containing allantoin and dimethicone which is applied to a BIOfrequency chip bandage backing. One BIOfrequency chip bandage is removed from the individually wrapped package and applied sticky side down to the skin. The package material is discarded after removing the BIOfrequency chip bandage. Allantoin is present in a 2% concentration. Allantoin also called 5-Ureidohydantoin; Glyoxyldiureide has a chemical designation is (RS)-(2,5-dioxoimidazolidin-4-yl)urea and has a molecular weight of 158.11544 g/mol. Allantoin has been shown benefits in preventing excessive scarring and promoting physiological scar formation when treatment is initiated early. 1 Dimethicone, also referred to as a-(Trimethylsilyl)-w-methylpoly[oxy(dimethylsilylene)] and other silicone-based products for scar management have been available for the past 30 years and are recommended in the current guidelines as the “gold standard” option for the prevention and treatment of hypertrophic scars and keloids. 2-5 The BIOfrequency chip is programed with bioactive frequencies using longitudinal electromagnetic (scalar waves) that are recognized by the body. The bioactive frequencies from the chip complement the active ingredients allantoin and dimethicone.
Indications & Usage
INDICATION Colliginix BIOfrequency Chip Bandage is a formulation for use in patients greater than 12 years in age to assist in the temporary support of wound healing, minor cuts, scrapes and burns, while improving scar appearance. One Colliginix BIOfrequency chip bandage should be administered to the wound or scar site every 8-12 hours once or twice daily. Remain hydrated: The Colliginix BIOfrequency Chip performs optimally when the body is adequately hydrated.
Dosage & Administration
Colliginix BIOfrequency Chip Bandage contains 5% dimethicone and 2% allantoin on the backing of each bandage. Persons 12 years and over apply 1 to 2 Colliginix BIOfrequency Chip bandages to affected area not more than two (2) times daily. Colliginix BIOfrequency Chip bandages should be worn for 8 hours at a time and no more than 12 hours within a 24-hour period. Children under 12 years, consult a physician before use. Instructions for Use: Clean and dry affected area. Shaving excess hair may help adhesion of biofrequency chip bandage. Open an individually sealed package and remove the biofrequency chip bandage and apply sticky side directly to affected area. Apply one to two biofrequency chips to affected area not more than two (2) times daily. Wash hands with soap after applying Colliginix BIOfrequency Chip bandage. Use biofrequency chip bandage immediately after opening individually sealed package. Do not use biofrequency chips stored outside the individually sealed package. Fold used Colliginix BIOfrequency Chip bandage so that the adhesive side sticks to itself and safely discard used Colliginix BIOfrequency Chips where children and pets cannot get to them.
Warnings & Precautions
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 Colliginix BIOfrequency chip bandage. It is important for patients to store and dispose of Colliginix BIOfrequency chip bandage out of the reach of children and pets. For external use only. The Colliginix BIOfrequency chip bandage may interfere with the operation of a cardiac pacemaker or defibrillator. Consultation with the attending cardiologist is recommended. The Colliginix BIOfrequency chip bandage should be removed prior to any imaging procedures (e.g. CT scan, X-ray, MRI, etc.). The Colliginix BIOfrequency chip bandage should not be used if there are mental or physical conditions that may preclude compliance with physician instructions. Do not use on infected skin, deep puncture wounds, animal bites, serious burns or blistered areas. PRECAUTIONS: When traveling by air, do not wear the Colliginix BIOfrequency chip bandage 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. Colliginix is only recommended for use on intact skin. The contact of Colliginix 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. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Nonclinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not been evaluated in animals. ADVERSE REACTIONS: The most common adverse reactions are application site reactions, including dermatitis, irritation, itching or scaling. These tend to be dose-limiting and diminish with time. If severe erythema, edema, vesicle formation (e.g., vesicular rash), or crusting develops, Colliginix should be discontinued until skin integrity is restored. Therapy may be reinitiated with less frequent application.
Contraindications
Known hypersensitivity to allanoitin, dimethicone or any component of the product.
Purpose
PURPOSE Colliginix BIOfrequency Chip Bandage purpose is to assist in the temporary support of minor cuts, scrapes and burns, while improving scar appearance.
Keep Out of Reach of Children
KEEP OUT OF REACH OF CHILDREN Keep the Colliginex BIOfrequency Chip Bandage and any medication out of reach of children.
Storage & Handling
STORAGE 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 can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.
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