Oxygen
FDA Label NDC 64540-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Austin Respiratory Equipment,inc for the product Oxygen (NDC 64540-011). 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

USP

   UN: 1073          

 CAS NO:7782-44-7

_________________________________________________________________

WARNING

EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE.

VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN

CONTACT WITYH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR

IMPACT.  CAN CAUSE SEVERE FROSTBITE. 

For emergency use only when administered by properly trained personnel for

Oxygen deficiency and resuscitation. For all other medical applications Rx only

Federal law prohibits dispensing without a prescription. WARNING: Uninterrupted

Use of high concentrations of oxygen over a long duration, without monitoring its

Effect 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.  Federal law requires that this Container be Refilled with oxygen U.S.P.

only by Establishments Registered as Drug Producer in accordance with the Federal

Food, Drug and Cosmetic Act.

KEEP OUT OF REACH OF CHILDERN.

DO NOT REMOVE THIS PRODUCT LABEL.

Produced by Air Liquefaction.

Directions for use:Always keep container in upright position↑. Do not change or force fit connections. Keep oil, grease, and combustibles away. No smoking in cylinder area. use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or on clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use suitable hand truck for container movement.

Avoid spills. Do not walk or roll equipment over spills. Cylinder temperature should not exceed 52°C (125°F).Close valve after each use and when empty. Use a back flow preventive device in the piping. Use in accordance with Safety data Sheet. (SDS).

FIRST AID: in case of Frostbite: obtain medical treatment immediately.

​SIZE                                CONTENT

​                                                                     21                            16,750 LITERS

                                                                     31                            24,950 LITERS

                                                                     41                            33,500 LITERS

AUSTIN RESPIRATORY EQUIPMENT, INC.

1676 N. Belcher Road

Clearwater, FL. 33765

(727) 467-0606

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