Label: OXYGEN gas
- NDC Code(s): 64097-0001-1, 64097-0001-2, 64097-0001-3, 64097-0001-4
- Packager: Alternacare Home Health Services
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated October 21, 2023
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WARNINGS AND PRECAUTIONS
WARNING:
HIGH PRESSURE GAS CYLINDERImproper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE. Keep out of the reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. Do not use caustic paint strippers. Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs. Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves and assemblies must be specially cleaned for oxygen. Verify cylinder content and pressure monthly, or more frequently if required. Store and use with adequate ventilation.
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WARNINGS
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 used in conjunction with resuscitative equipment.
WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATED COMBUSTION
Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure.
Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition.
Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance wiith the Federal Food, Drug, and Cosmetic Act.
Pursuant to recommendations by Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125 F
DO NOT REMOVE THIS PRODUCT LABEL
Use a back flow preventative device in the piping.
Use only in accordance with product instructions and material safety data sheet.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64097-0001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99.5 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64097-0001-1 142 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 2 NDC:64097-0001-2 235 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 3 NDC:64097-0001-3 393 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 4 NDC:64097-0001-4 646 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1996 Labeler - Alternacare Home Health Services (946763364) Registrant - Alternacare Home Health Services (946763364) Establishment Name Address ID/FEI Business Operations Alternacare Home Health Services 946763364 manufacture(64097-0001)