{"effective_time":"20251022","id":"3e78d4bf-5362-fd21-e063-6294a90ab5e1","openfda":{"application_number":["NDA205767"],"brand_name":["Oxygen"],"generic_name":["OXYGEN"],"is_original_packager":[true],"manufacturer_name":["AGL Inhalation Therapy Co."],"package_ndc":["17575-001-01","17575-001-02","17575-001-03","17575-001-04","17575-001-05","17575-001-06","17575-001-07","17575-001-08","17575-001-09","17575-001-10","17575-001-11","17575-001-12","17575-001-13","17575-001-14"],"product_ndc":["17575-001"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["RESPIRATORY (INHALATION)"],"rxcui":["312172"],"spl_id":["3e78d4bf-5362-fd21-e063-6294a90ab5e1"],"spl_set_id":["52bfd8c0-d181-4eef-90f5-d8bc9d1103fb"],"substance_name":["OXYGEN"],"unii":["S88TT14065"]},"package_label_principal_display_panel":["Produced by Air Liquefaction OXYGEN, COMPRESSED USP UN1072 WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx REQUIRED. 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 manufacturer 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 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 piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. Manufactured by: AGL CERTIFIED ISO 9001 AGL Inhalation Therapy Co. 600 Route 46 West Clifton, NJ 07015 NJ Tel: 973-478-5000 NY Tel: 845-561-5900 CAS 7782-44-7 NO SMOKING NO VAPING DO NOT REMOVE THIS PRODUCT LABEL oxygen 2025"],"set_id":"52bfd8c0-d181-4eef-90f5-d8bc9d1103fb","spl_product_data_elements":["Oxygen Oxygen OXYGEN OXYGEN"],"version":"14"}