FDA label 07e0c598-2cda-461d-8b75-9e476df1c8a9

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
1be809d6-aabe-4430-b9b1-528f855b8508
SPL ID
07e0c598-2cda-461d-8b75-9e476df1c8a9
Version
6
Effective date
2018-10-09
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:20

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 and cautions

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if the patient develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Flammability warning: Flammable: Avoid open flames or sources of ignition. Do not store above indicated temperatures. Back page of Complete Instructions: Caution: Federal law restricts this device to sale by or on the order of a licensed professional. Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document. Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group. Inc. P 877.236.4408 F 801.256.9287 4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A. www.caogroup.com SAL-CAI001 REV7 30MAY2018

Reported adverse events (FAERS/openFDA)#

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