Oxygen
FDA Label NDC 11331-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Welding & Gas for the product Oxygen (NDC 11331-001). 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 package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

Oxygen, Refrigerated Liquid, U.S.P. UN 1073


WARNING:

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. EXTREMELY COLD, OXIDIZING LIQUID AND GOS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE. Keep oil, grease and combustibles away. No smoking in container area. Use only equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop or handle container roughly. Use hand-truck for container movement. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Use in accordance with Material Safety Date Sheet.

FIRST AID: IN CASE OF FROSTBITE, obtain professional medical treatment immediately.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. 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. Use only with pressure reducing equipment and apparatus designed for oxygen.


DO NOT REMOVE THIS PRODUCT LABEL


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