Label: OXYGEN HELIUM MIXTURE 30/70 gas

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

Drug Label Information

Updated December 18, 2017

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  • PRINCIPAL DISPLAY PANEL

    COMPRESSED GAS, N.O.S. (70% HELIUM USP, 30% OXYGEN USP) UN3156 NON-FLAMMABLE GAS 2 OXIDIZER 5.1
    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: MAY CAUSE OR INTENSIFY FIRE. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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 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. CAS HELIUM 7440-59-7 OXYGEN 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
    ALL-GAS THE AERO ALL-GAS COMPANY 3150 MAIN ST. . HARTFORD, CT 06120 (860) 278-AERO (2376) he70ox30

  • INGREDIENTS AND APPEARANCE
    OXYGEN HELIUM MIXTURE 30/70 
    oxygen helium mixture 30/70 gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10014-018
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN300 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HELIUM (UNII: 206GF3GB41) 700 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10014-018-03425 L in 1 CYLINDER; Type 0: Not a Combination Product10/06/1972
    2NDC:10014-018-04705 L in 1 CYLINDER; Type 0: Not a Combination Product10/06/1972
    3NDC:10014-018-057108 L in 1 CYLINDER; Type 0: Not a Combination Product10/06/1972
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584010/06/1972
    Labeler - Aero All Gas Company (004532065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aero All Gas Company004532065repack(10014-018)