FDA label 204f0aa3-71ac-4ffa-b5a7-21ef8182c207

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
3e52aaa4-7857-45ce-a6d5-befc5da28ce1
SPL ID
204f0aa3-71ac-4ffa-b5a7-21ef8182c207
Version
4
Effective date
2016-02-25
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:03:13

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.