Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 49972-001-01, 49972-001-02, 49972-001-03, 49972-001-04, view more49972-001-05, 49972-001-06, 49972-001-07, 49972-001-08, 49972-001-09, 49972-001-10, 49972-001-11, 49972-001-12, 49972-001-13, 49972-001-14, 49972-001-15, 49972-001-16, 49972-001-17, 49972-001-18, 49972-001-19, 49972-001-20, 49972-001-23, 49972-001-24, 49972-001-25, 49972-001-26, 49972-001-27, 49972-001-28, 49972-001-29, 49972-001-30, 49972-001-31, 49972-001-32, 49972-001-33, 49972-001-34 - Packager: Praxair Distribution Southeast LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated July 22, 2013
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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
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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
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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
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct 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)