Oxygen
FDA Label NDC 10671-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Air Liquide America L.p. for the product Oxygen (NDC 10671-011). 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 oxygen refrigerated liquid usp label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Refrigerated Liquid Usp Label

WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT.  CALL 1-800-231-1366 FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

Oxygen, Refrigerated Liquid USP

UN 1073   Rx ONLY

AIR LIQUIDE
P.O. BOX 460229
Houston, TX 77056

M64L-2

WARNING: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  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.

Store and use with adequate ventilation.  Keep oil, grease and combustibles away.  No smoking in container area.  Do not use or store near heat or open flame.  Use only with equipment cleaned for oxygen service.  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 suitable hand truck for container movement.  Avoid spills.  Do not walk on or roll equipment over spills.  Container temperature should not exceed 125°F (52°C).  Close valve after each use and when empty.  Use in accordance with Material Safety Data Sheet.

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

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.  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.

CAUTION: Federal law prohibits dispensing without prescription.

Produced by Air Liquefaction.

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.  TRANSFILLING OF THIS LIQUID OR GAS IS PROHIBITED.

DO NOT REMOVE THIS PRODUCT LABEL.






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