Oxygen Gas
FDA Label NDC 62179-1234

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Intermountain Home Care for the product Oxygen (NDC 62179-1234). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen compressed u.s.p. un 1072, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen Compressed U.S.P. Un 1072

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 ACCELERATES 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 with 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 preventive device in the piping.

Use only in accordance with product instructions and material safety data sheet.

WARNING:

HIGH PRESSURE GAS CYLINDER

Improper 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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