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| Product NDC Code | 48546-0006 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Oxygen |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | RESPIRATORY (INHALATION) | ||||||
| Dosage Form | GAS | ||||||
| RxCUI drug identifier | 312172, 312173, 312174 |
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| Application Number | NDA205767 | ||||||
| Labeler Name | Indiana Oxygen Company Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Spl product data elements
Usually a list of ingredients in a drug product.OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN OXYGEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.OXYGEN COMPRESSED LABEL OXYGEN COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) 114619 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 in conjunction with resuscitative equipment. Produced by Air Liquefaction. 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 if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction 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 sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL. INDIANA OXYGEN COMPANY 6099 West Corporate Way, Indianapolis, IN 462278 317-290-0003 CONTENTS: LTRS: _____ CU. FT. _____ OXYGEN COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) 114621 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 in conjunction with resuscitative equipment. Produced by Air Liquefaction. 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 if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction 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 sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL. INDIANA OXYGEN COMPANY 6099 West Corporate Way, Indianapolis, IN 462278 317-290-0003 CONTENTS: LTRS: _____ CU. FT. _____ OXYGEN COMPRESSED USP UN 1072 C.A.S. NO. 7782-44-7 Contents ______________________ LTRS. __________ CU. FT. __________ OXYGEN 2 (R-K14) 11623 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 in conjunction with resuscitative equipment. Produced by Air Liquefaction. 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 if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction 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 sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODUCT LABEL. INDIANA OXYGEN COMPANY 6099 West Corporate Way, Indianapolis, IN 462278 317-290-0003 OXYGEN COMPRESSED USP UN 1072 C.A.S. NO. 7782-44-7 OXYGEN 2 (R-K14) 114919 INDIANA OXYGEN COMPANY 6099 West Corporate Way, Indianapolis, IN 462278 317-290-0003 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 if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction 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 sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODUCT LABEL. 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 in conjunction with resuscitative equipment. Produced by Air Liquefaction. CYLINDER TYPE LITERS CYLINDER TYPE LITERS R 570 M9 255 E 660 M6 170 D 400 Other ____________ O2 HPSL1 O2 HPSL2 O2 Body 3 O2 Body 4
OXYGEN REFRIGERATED LABEL REFRIGERATED LIQUID OXYGEN, REFRIGERATED LIQUID USP UN 1073 OXYGEN 2 (R-K14) 115073 ↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.↑ DO NOT CHANGE OR FORCE FIT CONNECTIONS. CONTENTS: PG OXURM 164610 (LITERS) PG OX35OM 145522 WARNING: USP 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 in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENFIFY FIRE: OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY COMBUSTIBLES IN CONTACT WITH LIQUIDE OXYGEN MAY EXPLODE ON IGNITION OT 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 if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOY change of force fit connections. Avoid spills. Do not walk or roll equipment over spills. Close valve after wach 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 REMOVE THIS PRODUCT LABEL. INDIANA OXYGEN COMPANY 6099 West Corporate Way, Indianapolis, IN 462278 317-290-0003 O2 REF LIQ
OXYGEN CERTIFICATE OF ANALYSIS Certificate of Analysis - Oxygen USP CUSTOMER ___________________ VENDOR / SUPPLIER ________________________ ____________________________ Indiana Oxygen Co ____________________________ 6099 W Corporate Way ____________________________ Indianapolis, IN 46278 THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT # _______________________ 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 INENSURING COMPLIANCE WITH 21 CFR 211.84. THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITHOTHER 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 USP SPECIFICATION LOT ANALYSIS IDENTIFICATION PASS ODOR PASS CARBON DIOXIDE LESS THAT 0.03% CARBON MONOXIDE LESS THAT 0.001% ASSAY GREATER THAN 99.0% * NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction process from the tests 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 indicated below: Paramagnetic Analyzer Model # _________________________ Supplier Signature ___________________________ Date _____________ COA
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API