Oxygen
FDA Label NDC 69044-123

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Utah for the product Oxygen (NDC 69044-123). 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 cylinder label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Cylinder Label

WARNING

For Emergency use only when administered by properly trained personnel for oxygen deficiency or resuscitation. For all other medical applicatios.

RX ONLY

Uninterrupted use of high concentrations of oxygen for more than five hours may be harmful. Do not attempt to use on patients who have stopped breathing unless in conjunction with resuscitative equipment.

PRESSURE:_________PSIGat 70 F

Cylinder Size:_________

Contents:__________ Liters/Cu.Ft.

STORAGE AND HANDLING WARNING
Keep out of reach of children.

CONTENTS UNDER HIGH PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION. Keep free from oil or grease. Do not use or store near heat or open flame and use only with equipment condition for oxygen service.

REFILL NOTICE

Federal law requires that this container be refilled with oxygen U.S.P. only by estalishements registered as a drug producer in accordance with the Federal Food, Drug and Cosmetic Act.

OXYGEN DISPENSING DEVICE NOTICE

For medical use only with pressure regulator designed for oxygen.

WARNING: The amount of oxygen contained may be insufficient for medical use unless used with the device indicaed and for the purpose indicated in the device label.

CGA VALUE WARNING

HIGH PRESSURE OXIDIZING GAS: Open valve slowly. Close valve after each use and when empty. Use only with Pressure reducing equipment and apparatus designed and cleaned for oxygen service and related for cylinder pressure.

Cylinder Label (Cylinderlabel)

Cylinder Label (Cylinderlabel)

* Please review the disclaimer below.