Oxygen Gas
FDA Label NDC 69847-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Respiratory Care Partners, Inc for the product Oxygen (NDC 69847-001). 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, oxygen refrigerated liquid label, oxygen certificate of analysis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Compressed Label

OXYGEN COMPRESSED USP  UN 1072

PRODUCED BY AIR LIQUEFACTION.

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 PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURES SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS)  DO NOT REMOVE PRODUCT LABEL

CAS 7782-44-7  17030 (08/07)

CONTENTS________________________________

Oxygen Refrigerated Liquid Label

OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073

GROSS WT. __________LBS _______OZ

NET WT. _________LBS  __________OZ

SIZE _______ CONTENTS ___________ LITERS ______________

Rx ONLY. OXYGEN PRODUCED BY AIR LIQUEFACTION  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. 

WARNING: DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  DO NOT DROP.  USE HAND TRUCK SPECIFICALLY DESIGNED FOR LIQUID CYLINDER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH BOC GASES MSDS G-102

IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

TO BE REFILLED BY A BOC GASES AUTHORIZED FACILITY ONLY.

CAS 7782-44-7 AIRCO  DO NOT REMOVE PRODUCT LABEL  MG 1644E LSP 6004E 5/98

Oxygen Certificate Of Analysis


               CUSTOMER ___________________  VENDOR / SUPPLIER ________________________  THIS LETTER IS TO PROVIDE YOU WITH THE
               CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT NUMBER _______________________ SUPPLIED TO YOU IN
               CYLINDERS / VESSELS BY OUR LOCATION

               These cylinders were filled in accordance with the Standard Operating Procedures utilized for the manufacture of Medical Gases.  By
               following these procedures, our location ensures that products are safely manufactured in compliance with FDA’s Current Good Manufacturing Practices
               (cGMP) Regulations.  
               CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS
               CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT
               LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE
               NOT CERTIFIED FOR INSTRUMENT CALIBRATION.

TEST REQUIREMENT           USP SPECIFICATION                  LOT ANALYSIS
IDENTIFICATION                         PASS
ODOR                                        PASS
CARBON DIOXIDE                    LESS THAT 0.03%
CARBON MONOXIDE                LESS THAT 0.001%
ASSAY                                     GREATER THAN 99.0%

*  NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction process from the tests for Carbon Dioxide and Carbon Monoxide.  
               As our label states, the Oxygen USP being supplied is manufactured by the Air Liquefaction Process.

The methodology being used to perform the USP / NF Test for
               Assay is indicated below:   Paramagnetic Analyzer    Model # _________________________
               J 700 a1

REVISION 1.0
               CERTIFICATE OF ANALYSIS - OXYGEN USP

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