Oxygen
FDA Label NDC 10671-010

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 10671-010). 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 compressed usp sl label, oxygen compressed usp label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Compressed Usp Sl 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, COMPRESSED USP  OXYGEN 2

UN 1072  Rx ONLY    B05    M61-2

WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. 

Secure cylinder and provide adequate ventilation in storage and use.  Keep oil and grease away.  No smoking in cylinder area.  Do not use or store near heat or open flame.  Keep out of reach of children.  Use only with equipment cleaned for oxygen service and rated for cylinder pressure.  Cylinder temperatures should not exceed 125°F (52°C).  Open valve slowly.  Close valve after each use and when empty.

Return with at least 25 PSIG pressure. 

Use in accordance with Material Safety Data Sheet.

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.  Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act.

Produced by Air Liquefaction.

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

DO NOT REMOVE THIS PRODUCT LABEL.

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

Oxygen Compressed 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, COMPRESSED USP  OXYGEN 2

UN 1072  Rx ONLY  

WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION.

Secure cylinder and provide adequate ventilation in storage and use.  Keep oil and grease away.  No smoking in cylinder area.  Do not use or store near heat or open flame.  Keep out of reach of children.  Use only with equipment cleaned for oxygen service and rated for cylinder pressure.  Cylinder temperatures should not exceed 125°F (52°C).  Open valve slowly.  Close valve after each use and when empty. Use a back flow preventive device in the piping.

Return with at least 25 PSIG pressure. 

Use in accordance with Material Safety Data Sheet.

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.  Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act.

 Produced by Air Liquefaction.

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

DO NOT REMOVE THIS PRODUCT LABEL.


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

M62-3   L12

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