FDA Label for Oxygen
View Indications, Usage & Precautions
Oxygen Product Label
The following document was submitted to the FDA by the labeler of this product South Jersey Welding Supply. 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.
Oxygen Hp Label
OXYGEN COMPRESSED USP
UN 1072
PRODUCED BY AIR LIQUEFACTION
OXYGEN 2
18035 (04/15)
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacture in accordance with the Federal Food, Drug, and Cosmetic Act.
DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak of safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of consruction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from direct sunlight whem ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
SOUTH JERSEY WELDING SUPPLY
94 W FOREST GROVE RD
VINELAND, NJ 08360•856-778-4440
CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL
Oxygen Certificate Of Analysis
South Jersey Welding Supply
CERTIFICATE OF ANALYSIS
OXYGEN (USP)
CUSTOMER
This letter is to provide you with the certification you requested for Oxygen, USP, Lot# ________________
supplied to you in cylinder / 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 the 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 customer's obligation
to comply with other portions of 21 CFR 210 and 211, including but not limited to 21 CFR 211.265
(finished product testing) for cylinders and vessels filled from these supply cylinders. These
cylinders are not certfiied for instrument calibration purposes.
Test Requirements USP Specification Lot Analysis
IdentifIcation Pass
Odor Pass
Carbon Dioxide Less than 0.03%
Carbon Monoxide Less than 0.001%
Assay Greater than 99.0%
NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction Process
from the test for Carbon Dioxide and Carbon Monoxide. As our label states, the Oxygen USP
being supplied is manufactured by the Air Liquefaction Process.
The methodology being used to perform the USP / NF test for Assay is the
Servomex Model 0A244D
Supplier Signature __________________________ Date ___________________
EXP 00-0000
SOUTH JERSEY
SCF 0000
WELDING SUPPLY
LOT 00000000
Oxygen Refrigerated Liq Label
REFRIGERATED LIQUID
OXYGEN REFRIGERATED LIQUID USP UN1073 OXYGEN 2
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children.
Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacture in accordance with the Federal Food, Drug, and Cosmetic Act.
Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak of safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of consruction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. Do not walk or roll equipment over spills. 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 ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advise/attention.
CAS: 7782-44-7
DO NOT REOVE THIS PRODUCT LABEL
SOUTH JERSEY WELDING SUPPLY
94 W FOREST GROVE RD
VINELAND, NJ 08360•856-778-4440
41533 (01/15)
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