Oxygen by Praxair Distribution Southeast LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Praxair Distribution Southeast LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

UN1072 OXYGEN, COMPRESSED USP WARNING! HIGH-PRESSURE, OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil, grease and combustibles away. Keep away from heat, sparks and flame. Store and use with adequate ventilation to prevent oxygen accumulation. Use with equipment rated for cylinder pressure and cleaned for oxygen service. Use a backflow prevention device in any piping. Cylinder temperature should not exceed 125 deg F (52 deg C). Open valve slowly. Close valve after each use; keep closed even when empty. Always secure cylinder. Install cap, if provided, when not in use. Use per Praxair MSDS form P-4638 and safety booklets P-3499, P-14-153, and P-15-276; obtain from your local supplier. KEEP OUT OF REACH OF CHILDREN. 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 effects on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Rx ONLY CAS 7782-44-7 PRODUCED BY AIR LIQUEFACTION IN CASE OF EMERGENCY: CALL 1-800-645-4633 DISTRIBUTED BY PRAXAIR, INC., DANBURY DO NOT REMOVE THIS LABEL PMG-6 (07/08) Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113 DISTRIBUTED BY PRAXAIR, INC., DANBURY

PRINCIPAL DISPLAY PANEL

UN1072 OXYGEN, COMPRESSED USP DANGER! COMPRESSED, OXIDIZING GAS. MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Keep/store away from combustible materials. Keep reduction valves free from grease and oil. In case of fire: stop leak if safe to do so. Open valve slowly. Close valve after each use and when empty. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a backflow preventive device in the piping. Protect from sunlight when ambient temperature exceeds 52 deg C/125 deg F. Cylinder temperature should not exceed 52 deg C/125 deg F. Store and use in a well-ventilated place. Use per Praxair MSDS form P-4638, and safety booklets P-3499, P-14-153, and P-15-276; obtain from your local supplier. KEEP OUT OF REACH OF CHILDREN. Do not handle until all safety precautions have been read and understood. 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 effects on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment DO NOT REMOVE THIS LABEL Rx ONLY CAS 7782-44-7 PRODUCED BY AIR LIQUEFACTION IN CASE OF EMERGENCY: CALL 1-800-645-4633 DISTRIBUTED BY PRAXAIR, INC., DANBURY PMGB-6 (03/11) Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113

PRINCIPAL DISPLAY PANEL

UN1073 OXYGEN, REFRIGERATED LIQUID USP ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. DO NOT CHANGE OR FORCE-FIT CONNECTIONS LOT # NET CONTENTS WARNING! EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE. MAY CAUSE DIZZINESS OR DROWSINESS. ODOR: NONE Do not drop. Use suitable hand truck for container movement. Keep oil, grease, and combustibles away. Keep away from heat, sparks, and flame. Use with equipment cleaned for oxygen service. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield and gloves. Avoid spills. Do not walk on or roll equipment over spills. Store and use with adequate ventilation to prevent oxygen accumulation. Container temperature should not exceed 125 deg F (52 deg C). Use piping and equipment adequately designed to withstand any pressures to be encountered. Use a backflow prevention device in any piping. Close valve after each use; keep closed even when empty. Container discharge must be warmed to room temperature before breathing. Always secure container so it cannot be knocked over. Use per Praxair MSDS form P-4637 and safety booklets P-3499, P-14-153, and P-15-276 (obtain from your local supplier), and per manufacturer’s instructions for this container. RX ONLY FIRST AID: INHALATION—immediately remove to fresh air. If not breathing, give artificial respiration. Keep victim warm and at rest. Call a physician. Advise physician that the victim has been exposed to a high concentration of oxygen. FROSTBITE—Obtain medical treatment immediately. FOR SKIN CONTACT, immediately warm frostbite area with warm water not exceeding 105 deg F (41 deg C). In case of massive exposure, remove clothing while showering with warm water. Call a physician. FOR EYE CONTACT, flush eyes with warm water for at least 15 minutes. See a physician, preferably an ophthalmologist, immediately. 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 effects on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. DO NOT REMOVE THIS LABEL Rx ONLY CAS 7782-44-7 PRODUCED BY AIR LIQUEFACTION IN CASE OF EMERGENCY: CALL 1-800-645-4633 PMG-8 (07/08) Copyright @ 2002-2003, 2008. Praxair Technology, Inc.Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49972-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)	Oxygen	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49972-001-01	16424 L in 1 CYLINDER
2	NDC: 49972-001-02	14130 L in 1 CYLINDER
3	NDC: 49972-001-03	10987 L in 1 CYLINDER
4	NDC: 49972-001-04	9543 L in 1 CYLINDER
5	NDC: 49972-001-05	7985 L in 1 CYLINDER
6	NDC: 49972-001-06	7051 L in 1 CYLINDER
7	NDC: 49972-001-07	4361 L in 1 CYLINDER
8	NDC: 49972-001-08	3511 L in 1 CYLINDER
9	NDC: 49972-001-09	2350 L in 1 CYLINDER
10	NDC: 49972-001-10	708 L in 1 CYLINDER
11	NDC: 49972-001-11	595 L in 1 CYLINDER
12	NDC: 49972-001-12	425 L in 1 CYLINDER
13	NDC: 49972-001-13	142 L in 1 CYLINDER
14	NDC: 49972-001-14	198 L in 1 CYLINDER
15	NDC: 49972-001-15	7730 L in 1 CYLINDER
16	NDC: 49972-001-16	4332 L in 1 CYLINDER
17	NDC: 49972-001-17	2520 L in 1 CYLINDER
18	NDC: 49972-001-18	934 L in 1 CYLINDER
19	NDC: 49972-001-19	680 L in 1 CYLINDER
20	NDC: 49972-001-20	142 L in 1 CYLINDER
21	NDC: 49972-001-23	74566 L in 1 DEWAR
22	NDC: 49972-001-24	103757 L in 1 DEWAR
23	NDC: 49972-001-25	114228 L in 1 DEWAR
24	NDC: 49972-001-26	120574 L in 1 DEWAR
25	NDC: 49972-001-27	127237 L in 1 DEWAR
26	NDC: 49972-001-28	135487 L in 1 DEWAR
27	NDC: 49972-001-29	142785 L in 1 DEWAR
28	NDC: 49972-001-30	155794 L in 1 DEWAR
29	NDC: 49972-001-31	162140 L in 1 DEWAR
30	NDC: 49972-001-32	178957 L in 1 DEWAR
31	NDC: 49972-001-33	291916 L in 1 DEWAR
32	NDC: 49972-001-34	428355 L in 1 DEWAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		10/01/2007

Labeler - Praxair Distribution Southeast LLC (008455552)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution Southeast LLC		969017086	manufacture(49972-001)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution Southeast LLC		192167567	manufacture(49972-001)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution Southeast LLC		006734263	manufacture(49972-001)