Label: HELIUM, OXYGEN gas

  • NDC Code(s): 11054-041-01, 11054-041-02, 11054-041-03, 11054-041-04, view more
    11054-041-05
  • Packager: AIRGAS USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated November 9, 2019

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

  • PRINCIPAL DISPLAY PANEL

    COMPRESSED GAS, N.O.S.

    (80% HELIUM USP, 20% OXYGEN USP)

    UN1956

    NON-FLAMMABLE GAS 2

    837137 (02/17)

    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 preventative 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 52oC/125oF. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Seek medical advice/attention. CAS        HELIUM 7440-59-7            OXYGEN 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL

    Airgas, Healthcare

    An Air Liquide Company

    AIRGAS USA, LLC

    Radnor, PA 19087-5283

    Safety Data Sheets available at www. airgas.com

    80/20 Label

  • INGREDIENTS AND APPEARANCE
    HELIUM, OXYGEN 
    helium, oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11054-041
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM800 mL  in 1 L
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN200 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11054-041-01300 L in 1 CYLINDER; Type 0: Not a Combination Product10/14/1997
    2NDC:11054-041-02500 L in 1 CYLINDER; Type 0: Not a Combination Product10/14/1997
    3NDC:11054-041-032260 L in 1 CYLINDER; Type 0: Not a Combination Product10/14/1997
    4NDC:11054-041-044000 L in 1 CYLINDER; Type 0: Not a Combination Product10/14/1997
    5NDC:11054-041-054500 L in 1 CYLINDER; Type 0: Not a Combination Product10/14/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA20584310/14/1997
    Labeler - AIRGAS USA, LLC (078301808)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC003324498manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC006301766manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC032547507manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC072198059manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC079214355manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC079934743manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC620137799manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC790441885manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC827455879manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC879945632manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC946304797manufacture(11054-041)
    Establishment
    NameAddressID/FEIBusiness Operations
    AIRGAS USA, LLC947401071manufacture(11054-041)