Label: OXYGEN gas

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 3, 2011

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  • OXYGEN COMPRESSED LABEL

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

    OXYGEN U.S.P.  PRESSURE __________PSIG AT 70 F

    SIZE_________  CONTENTS________________ LITERS

    WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.  Rx ONLY.

    PRODUCED BY AIR LIQUEFACTION  CAS 7782-44-7  RETURN WITH 25 PSIG.

    SHOULDER LABEL

  • PRODUCT WARNINGS AND PRECAUTIONS

    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.  USER SHALL SECURE CYLINDER IN USE AND IN STORAGE.  USE IN UPRIGHT POSITION.  CLOSE VALVE AFTER EACH USE.  KEEP VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE, IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS.

    WARNING: 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.  KEEP OUT OF REACH OF CHILDREN.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63080-679
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.8 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63080-679-01165 L in 1 CYLINDER
    2NDC:63080-679-02210 L in 1 CYLINDER
    3NDC:63080-679-03415 L in 1 CYLINDER
    4NDC:63080-679-04683 L in 1 CYLINDER
    5NDC:63080-679-051724 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1995
    Labeler - Galloping Hill Surgical Corp. dba Allcare Medical (169078151)
    Registrant - Galloping Hill Surgical Corp. dba Allcare Medical (169078151)
    Establishment
    NameAddressID/FEIBusiness Operations
    AllCare Medical169078151manufacture