Oxygen Gas
FDA Label NDC 67525-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spectrum Gas Products, Inc for the product Oxygen (NDC 67525-100). 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, oxygen refrigerated liquid, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Compressed

OXYGEN COMPRESSED U.S.P.  UN 1072  OXYGEN 2

G13   

 Spectrum Gas Product
2381 E. Winston Road
Anaheim, CA 92806  (714)444-0477

SGP-1

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, CAUTION 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.

WARNING:HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Open valve slowly. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Close valve after each use and when empty. Produced by Air Liquefaction.

DO NOT REMOVE THIS PRODUCT LABEL


OXYGEN COMPRESSED U.S.P.   UN 1072  OXYGEN 2

OXYGEN, U.S.P. PRODUCED BY AIR LIQUEFACTION.

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

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

Secure cylinder in storage and use. Keep oil and grease away. No smoking in cylinder area. Open valve slowly. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Close valve after each use and when empty. 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, CAUTION 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. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment. Use only with pressure reducing equipment and apparatus designed for oxygen. Return with at least 25 PSIG pressure.

DO NOT REMOVE THIS PRODUCT LABEL.

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

SPG-2

Spectrum Gas products
2381 E. Winston Road
Anaheim, CA 92806
714-444-0477

G13


Oxygen Refrigerated Liquid

Oxygen, Refrigerated Liquid, USP UN 1073 Rx ONLY OXYGEN-2  PRODUCED BY AIR LIQUEFACTION

K13 SGP-9

Spectrum Gas Products
2381 E. Winston Road
Anaheim, CA 92806 (714)444-0477

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.

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODEON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.

 Keep oil, grease, and combustibles away. Use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdraw, 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. Container temperature should not exceed 52° C (125° F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).

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

DO NOT REMOVE THIS PRODUCT LABEL

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