Oxygen Gas
FDA Label NDC 58247-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Respitek Inc for the product Oxygen (NDC 58247-001). 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 oxygen compressed label, product warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen Compressed Label

OXYGEN COMPRESSED USP  UN 1072 OXYGEN-2  DO NOT REMOVE THIS PRODUCT LABEL

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY 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.

18278 (08/04)

Shoulder Label (Respitek Hp O2 Sl)

Shoulder Label (Respitek Hp O2 Sl)

Product Warnings And Precautions

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  CAS 7782-44-7  RETURN WITH 25 PSIG.  PRODUCED BY AIR LIQUEFACTION.  REFILLABLE ONLY BY RESPITEK OXYGEN SERVICE.

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