Label: OXYGEN gas

  • NDC Code(s): 67932-1313-1, 67932-1313-2, 67932-1313-3, 67932-1313-4, view more
    67932-1313-5, 67932-1313-8
  • Packager: Premier Oxygen LLC
  • 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 October 30, 2023

If you are a consumer or patient please visit this version.

  • GENERAL 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.  DO NOT REMOVE THIS PRODUCT LABEL.

  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED USP UN 1072  OXYGEN - 2  MEDICAL GAS Rx ONLY.  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 PRESCRIPTION.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONCENTRATION 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

    41014 (R07/05)  CAS 7782-44-7

    premier_hp_ox

    res

  • OXYGEN REFRIGERATED LIQUID LABEL

    REFRIGERATED LIQUID
    OXYGEN,
    REFRIGERATED
    LIQUID


    USP
    UN1073

    OXYGEN
    2
    (R-K14) 116046

    DANGER: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.
                   DO NOT CHANGE OR FORCE FIT CONNECTIONS.
                   MAY CAUSE OR INTENSIFY FIRE: OXIDIZER.
                   CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC
                      BURNS OR INJURY.
                   COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY
                   EXPLODE ON IGNITION OR IMPACT.

                   Do not handle until all safety precautions have been read
                     and understood.
                   Keep and store away from clothing and other combustible
                       materials.
                   Keep valves and fittings free from grease and oil.
                   Use and store only outdoors or in a well-ventilated place.
                   Wear cold insulating gloves, face shield, and eye protection.
                   In case of fire: Stop leak if safe to do so.
                   Use aback flow preventive device in the piping.
                   Use only with equipment of compatible materials of construction
                     and rated for cylinder pressure.
                   Use only with equipment cleaned for oxygen service.

    DO NOT change or force fit connections.
    Avoid spills. Do not walk on or roll equipment over spills.
    Close valve after each use and when empty.
    Always keep container in upright position.
    Read and follow the Safety DataSheet (SDS) before use.

    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 01 arterial blood, 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.
                      Federal law requires that this container be refilled with oxygen USP only by establishments
                      registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.

    FIRSTAID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not
    rub affected area. Get immediate medical advice/attention.

    DO NOT REMOVE THIS PRODUCT LABEL.

    Premier Oxygen, LLC
    2185 NE Spalding Avenue
    Grants Pass, OR 97526
    (888) 977•9339

    1073 Dewar

    res

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67932-1313
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.5 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67932-1313-1165 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
    2NDC:67932-1313-2425 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
    3NDC:67932-1313-3680 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
    4NDC:67932-1313-4255 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
    5NDC:67932-1313-51750 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
    6NDC:67932-1313-826 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1988
    Labeler - Premier Oxygen LLC (013568474)
    Registrant - Premier Oxygen LLC (013568474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Oxygen LLC013568474manufacture(67932-1313)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Oxygen LLC140880423manufacture(67932-1313)