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 Air Source Industries 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 Product Label
NITROGEN COMPRESSED NF UN 1066 RX ONLY
E15 A AIR SOURCE INDUSTRIES, INC.
3976 Cherry Ave., LONG BEACH, CA 90807
In CA (800) 295-4271 (562) 426-4017
NON-FLAMMABLE GAS 2 AS-10
RX ONLY. 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 the hazards, contraindications and side effects, and the precautions to be taken. WARNING:CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: remove person to fresh air and keep comfortable for breathing Get medical advice/attention.
CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL
Nitrogen Refrigerated Liquid Product Label
NITROGEN REFRIGERATED LIQUID NF UN 1977 RX ONLY
C15 A AIR SOURCE INDUSTRIES, INC.
3976 Cherry Ave., LONG BEACH, CA 90807
In CA (800) 295-4271 (562) 426-4017
NON-FLAMMABLE GAS 2 AS-22
RX ONLY. 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 the hazards, contraindications and side effects, and the precautions to be taken. WARNING:CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. Use a back flow preventive device in the piping. DO NOT change or force fit connections. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area.Get immediate medical advice/attention.
CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL
Nitrogen Certificate Of Analysis
USTOMER ___________________ 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
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