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

  • NDC Code(s): 42602-008-01, 42602-008-02, 42602-008-03
  • 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 OXIDIZING, N.O.S. LABEL 30% OXYGEN USP BALANCE HELIUM, USP

    NON-FLAMMABLE GAS 2     OXIDIZER 5.1
    Compressed gas, oxidizing, n.o.s. 

    (Oxygen, Helium)
    UN 3156                                                                                                                    SPG TCMD3

                                                                                                                                     Part Number

    ___________________________________________________________________________

                                                                       Medical Gas Mixture
    30% 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.

    DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE OR
    INTENSIFY FIRE; OXIDIZER.

    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. Use a back 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. Open valve slowly. 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 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 TCMD3 Part Numbe                            898 W. Gowen Rd., Boise, ID 83507                            898 W. Gowen Road

                                                                                                                                                    Boise, ID 83507

                                                                                                                                                    800-657-6572

    UN 3156 HeliOx 30

    res

  • INGREDIENTS AND APPEARANCE
    COMPRESSED GAS OXIDIZING, N.O.S. 
    oxygen, helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42602-008
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN30 L  in 100 L
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM70 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42602-008-018496 L in 1 CYLINDER; Type 0: Not a Combination Product09/01/2008
    2NDC:42602-008-025664 L in 1 CYLINDER; Type 0: Not a Combination Product09/01/2008
    3NDC:42602-008-03566.4 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(42602-008) , transfill(42602-008)