Label: COMPRESSED GAS, N.O.S.- oxygen, helium gas

  • NDC Code(s): 42602-007-01, 42602-007-02, 42602-007-03
  • Packager: Norco, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated May 20, 2024

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  • COMPRESSED GAS, N.O.S. LABEL 20.6% OXYGEN BALANCE HELIUM, USP

    Compressed gas, n.o.s.
    (Oxygen, Helium)
    UN1956                                                                                                        SPG TCMD2

                                                                                                                        Part Number

    ___________________________________________________________________________

                                                              Medical Gas Mixture
    20.6% Oxygen, USP                                                                                   CAS: 7782-44-7
    Balance Heliun, 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
                         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 ACCIDENTALLY INHALED; Remove to fresh air and keep comfortable for breathing. Get
                         medical advice/attention.

    ___________________________________________________________________________________________________
    Lot No: x-xxx-xxx – Volume 300                   NorLAB                     In Emergency Call: 1-800-424-9300
    Serial Number: T-113017                           To Order Call: 800-657-6672                                   NorLab
    SPG TCMD2                                                                                                                   898 W. Gowen Road                                       

    Part Number                                                                                                                       Boise, ID 83507

                                                                                                                                            800-657-6572

    UN1956 nos 20.6

    res

  • INGREDIENTS AND APPEARANCE
    COMPRESSED GAS, N.O.S. 
    oxygen, helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42602-007
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN20.4 L  in 100 L
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM79.6 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42602-007-018496 L in 1 CYLINDER; Type 0: Not a Combination Product09/01/2008
    2NDC:42602-007-025664 L in 1 CYLINDER; Type 0: Not a Combination Product09/01/2008
    3NDC:42602-007-03566.4 L in 1 CYLINDER; Type 0: Not a Combination Product09/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas09/01/2008
    Labeler - Norco, Inc. (043694645)
    Registrant - Norco, Inc. (043694645)
    Establishment
    NameAddressID/FEIBusiness Operations
    Norco, Inc.962460528manufacture(42602-007) , transfill(42602-007)