FDA Label for Nitrogen
View Indications, Usage & Precautions
Nitrogen Product Label
The following document was submitted to the FDA by the labeler of this product Capweld Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Nitrogen Compressed Label
NITROGEN COMPRESSED NF UN 1066
CAUTION; HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION Store and use with adequate ventilation use equipment rated for cylinder pressure Close valve when not in use and when empty. Use in accordance with suppliers Material Safety Data Sheet.
FIRST AID: If inhaled, remove to fresh air. If not breathing, give
artificial respiration. If breathing is difficult, give oxygen. Call
a physician.
Do Not Remove this Product Label
Nitrogen Certificate Of Analysis
CUSTOMER ___________________ VENDOR / SUPPLIER ________________________ THIS LETTER IS TO PROVIDE YOU WITH THE
CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT NUMBER _______________________ SUPPLIED TO YOU IN
CYLINDERS / VESSELS BY OUR LOCATION
These cylinders were filled in accordance with the Standard Operating
Procedures utilized for the manufacture of Medical Gases. By
following these procedures, our location ensures that products are
safely manufactured in compliance with FDA’s Current Good Manufacturing
Practices
(cGMP) Regulations.
CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST
CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84. THIS
CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH
OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT
LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND
VESSELS FILLED FROM THESE SUPPLY CYLINDERS. THESE CYLINDERS ARE
NOT CERTIFIED FOR INSTRUMENT CALIBRATION.
TEST REQUIREMENT NF SPECIFICATION LOT ANALYSIS
IDENTIFICATION PASS
ODOR PASS
Oxygen LESS THAT 1.0%
CARBON MONOXIDE LESS THAT 0.001%
ASSAY GREATER THAN 99.0%
The methodology being used to perform the USP / NF Test for
Assay is indicated below: Paramagnetic Analyzer Model # _________________________
Electrochemical Analyzer Model # _________________________
Gas Chromatography Official USP/NF method
Supplier Signature ____________________________ Date _______________________
J 700 a2
General Warnings And Precautions
WARNING: Administration of nitrogen may be hazardous or contraindicated. For
use only by or under the supervision of a licensed practitioner who is
experienced in the use and administration of nitrogen and is familiar
with the indications, effects, dosages, methods, and frequency and
duration of administration and with hazards, contraindications, and
side effects and the precautions to be taken. Rx Only
* Please review the disclaimer below.