Oxygen
FDA Label NDC 49121-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Global Medical Llc for the product Oxygen (NDC 49121-001). 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 usp label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen Compressed Usp Label

OXYGEN COMPRESSED USP   UN 1072    OXYGEN 2

C.A.S. NO.  7782-44-7    GlobalMedical  8332 Bristol Ct. Suite 108  Jessup, MD 20794  800-528-1001

WARNING: HIGH PRESSURE OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

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) 

DO NOT REMOVE THIS PRODUCT LABEL.

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. 

PRODUCED BY AIR LIQUEFACTION.

Size          Contents   

M6            170 Liters

C               248 Liters

D               415 Liters

E               682 Liters

H               6910 Liters

Other         ______ Liters

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