Oxygen
FDA Label NDC 59470-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Steve Gulick, Inc. for the product Oxygen (NDC 59470-001). 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

UN1073 OXYGEN, REFRIGERATED LIQUID USP

ALWAYS KEEP CONTINER IN UPRIGHT POSITION. DO NOT CHANGE OR FORCE-FIT CONNECTIONS

CONTENTS

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 effects on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

Produced by Air Liquefaction

WARNING! EXTREMELY COLD, OXIDIZING LIQUID AND GAS 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. Use with 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 .Use suitable hand truck for container movement.

Avoid spills. Do not walk on or roll equipment over spills

Cylinder temperature should not exceed 125°F (52°C)

Close valve after each use and when empty.

Use backflow preventative device in the piping.

Use in accordance with the Material Safety Data Sheet (MSDS)

FIRST AID: IN CASE OF FROSTBITE obtain medical treatment immediately. CAS 7782-44-7

DO NOT REMOVE THIS LABEL

ILLIANA MEDICAL EQUIPMENT and SUPPLY

912 Vermillion * Danville, IL 61832

217-442-0654

47136

(R1005)

Oxygen One (Oxygen1)

Oxygen One (Oxygen1)

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