Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 76133-001-01, 76133-001-02, 76133-001-03, 76133-001-04, view more76133-001-05, 76133-001-06, 76133-001-07, 76133-001-08, 76133-001-09, 76133-001-10, 76133-001-11, 76133-001-12, 76133-001-13, 76133-001-14, 76133-001-15, 76133-001-16, 76133-001-17, 76133-001-18, 76133-001-19, 76133-001-20, 76133-001-21, 76133-001-22, 76133-001-23, 76133-001-24, 76133-001-25, 76133-001-26, 76133-001-27, 76133-001-28, 76133-001-29, 76133-001-30, 76133-001-31, 76133-001-32 - Packager: Praxair Distribution Mid-atlantic, Llc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 19, 2015
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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:76133-001 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:76133-001-01 16424 L in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:76133-001-02 14130 L in 1 CYLINDER; Type 0: Not a Combination Product 3 NDC:76133-001-03 10987 L in 1 CYLINDER; Type 0: Not a Combination Product 4 NDC:76133-001-04 9543 L in 1 CYLINDER; Type 0: Not a Combination Product 5 NDC:76133-001-05 7985 L in 1 CYLINDER; Type 0: Not a Combination Product 6 NDC:76133-001-06 7051 L in 1 CYLINDER; Type 0: Not a Combination Product 7 NDC:76133-001-07 4361 L in 1 CYLINDER; Type 0: Not a Combination Product 8 NDC:76133-001-08 3511 L in 1 CYLINDER; Type 0: Not a Combination Product 9 NDC:76133-001-09 2350 L in 1 CYLINDER; Type 0: Not a Combination Product 10 NDC:76133-001-10 708 L in 1 CYLINDER; Type 0: Not a Combination Product 11 NDC:76133-001-11 595 L in 1 CYLINDER; Type 0: Not a Combination Product 12 NDC:76133-001-12 425 L in 1 CYLINDER; Type 0: Not a Combination Product 13 NDC:76133-001-13 142 L in 1 CYLINDER; Type 0: Not a Combination Product 14 NDC:76133-001-14 198 L in 1 CYLINDER; Type 0: Not a Combination Product 15 NDC:76133-001-15 7730 L in 1 CYLINDER; Type 0: Not a Combination Product 16 NDC:76133-001-16 4332 L in 1 CYLINDER; Type 0: Not a Combination Product 17 NDC:76133-001-17 2520 L in 1 CYLINDER; Type 0: Not a Combination Product 18 NDC:76133-001-18 934 L in 1 CYLINDER; Type 0: Not a Combination Product 19 NDC:76133-001-19 680 L in 1 CYLINDER; Type 0: Not a Combination Product 20 NDC:76133-001-20 142 L in 1 CYLINDER; Type 0: Not a Combination Product 21 NDC:76133-001-21 74566 L in 1 DEWAR; Type 0: Not a Combination Product 22 NDC:76133-001-22 103757 L in 1 DEWAR; Type 0: Not a Combination Product 23 NDC:76133-001-23 114228 L in 1 DEWAR; Type 0: Not a Combination Product 24 NDC:76133-001-24 120574 L in 1 DEWAR; Type 0: Not a Combination Product 25 NDC:76133-001-25 127237 L in 1 DEWAR; Type 0: Not a Combination Product 26 NDC:76133-001-26 135487 L in 1 DEWAR; Type 0: Not a Combination Product 27 NDC:76133-001-27 142785 L in 1 DEWAR; Type 0: Not a Combination Product 28 NDC:76133-001-28 155794 L in 1 DEWAR; Type 0: Not a Combination Product 29 NDC:76133-001-29 162140 L in 1 DEWAR; Type 0: Not a Combination Product 30 NDC:76133-001-30 178957 L in 1 DEWAR; Type 0: Not a Combination Product 31 NDC:76133-001-31 291916 L in 1 DEWAR; Type 0: Not a Combination Product 32 NDC:76133-001-32 428355 L in 1 DEWAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 10/01/2007 Labeler - Praxair Distribution Mid-atlantic, Llc (808461896) Establishment Name Address ID/FEI Business Operations Praxair Distribution Mid-atlantic, Llc 808461896 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 001355176 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 623107120 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 167418326 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 063205512 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 039755707 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 002246916 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 364098731 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 824679554 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 148052277 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 879317022 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 021450408 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 555510726 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 037432010 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 099430951 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 884877440 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 118788132 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 623107070 manufacture(76133-001) Establishment Name Address ID/FEI Business Operations Praxair Distribution, Inc. 623107088 manufacture(76133-001)