Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated January 1, 2010

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  • 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 ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN SERVICE.  USE A BACK FLOW PREVENTATIVE IN THE 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)

    OXYGEN SHOULDER LABEL.

  • GENERAL WARNINGS AND PRECAUTIONS

    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 oxygen content of arterial blood may be harmful.  Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful.  Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

    DO NOT REMOVE THIS PRODUCT LABEL

  • OXYGEN REFRIGERATED LIQUID LABEL

    OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073

    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 EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  STORE AND USE WITH ADEQUATE VENTILATION.  KEEP OIL, GREASE, AND COMBUSTIBLES AWAY.  NO SMOKING IN CONTAINER AREA.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP  USE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS).

    FIRST AID:  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

    OXYGEN REFRIGERATED LIQUID LABEL

  • 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

    OXYGEN COA

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52849-100
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52849-100-01396 L in 1 CYLINDER
    2NDC:52849-100-02663 L in 1 CYLINDER
    3NDC:52849-100-032266 L in 1 CYLINDER
    4NDC:52849-100-043455 L in 1 CYLINDER
    5NDC:52849-100-056910 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1952
    Labeler - Capweld Inc (033340977)
    Registrant - Capweld Inc (033340977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capweld Inc033340977manufacture