Label: OXYGEN/HELIUM 40/60 gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 2, 2022

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  • PRINCIPAL DISPLAY PANEL

    Compressed gas, n.o.s.

    (Oxygen, Helium)

    UN1956

    Medical Gas Mixture

    Oxygen, USP CAS: 7782-44-7

    Balance Helium, USP CAS: 7440-59-7

    Rx only

    WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

    WARNING CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

    Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.

    FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.

    DO NOT REMOVE THIS PRODUCT LABEL

    Matheson

    909 Lake Carolyn Pkwy

    Irving, TX 75039 oxygen helium

  • INGREDIENTS AND APPEARANCE
    OXYGEN/HELIUM 40/60 
    oxygen/helium 40/60 gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55037-630
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN400 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HELIUM (UNII: 206GF3GB41) 600 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55037-630-015900 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1987
    2NDC:55037-630-02640 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1987
    3NDC:55037-630-03620 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20588901/01/1987
    Labeler - MATHESON TRI-GAS, INC. (179092028)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.035676147manufacture(55037-630)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.045200315manufacture(55037-630)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.074768669manufacture(55037-630)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.111249868manufacture(55037-630)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.606686202manufacture(55037-630)
    Establishment
    NameAddressID/FEIBusiness Operations
    MATHESON TRI-GAS, INC.832779602manufacture(55037-630)