Label: HELIUM gas

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

Drug Label Information

Updated November 19, 2020

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  • PRINCIPAL DISPLAY PANEL

    HELIUM,
    COMPRESSED
    USP
    UN1046
    NON-FLAMMABLE GAS 2
    Rx ONLY. WARNING: Administration of Helium USP 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 Helium USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. 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 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 INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
    CAS: 7440-59-7  DO NOT REMOVE THIS PRODUCT LABEL.
    Roberts Oxygen Company, Inc.
    PO BOX 5507 Rockville, MD 20855
    301-948-8100

    image of cylinder label

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-008
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-008-01102 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    2NDC:46123-008-02374 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    3NDC:46123-008-03623 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    4NDC:46123-008-043880 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    5NDC:46123-008-055436 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    6NDC:46123-008-066910 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    7NDC:46123-008-078241 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586401/01/1967
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-008)