Label: HELIUM gas

  • NDC Code(s): 12213-710-12, 12213-710-13, 12213-710-20, 12213-710-21, view more
    12213-710-22, 12213-710-40, 12213-710-50, 12213-710-58, 12213-710-60
  • Packager: NexAir, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 13, 2026

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  • PRINCIPAL DISPLAY PANEL

    UN1046
    HELIUM, COMPRESSED USP
    DO NOT REMOVE THIS LABEL
    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 preventive device in the piping. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Close valve after each use and when empty. Do not inhale for recreational use. Protect form sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AIR: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. WARNING: Administration of helium 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 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.
    Rx ONLY
    IN CASE OF EMERGENCY: CALL 1-888-639-2474
    CAS: 7440-59-7
    nexAir
    Distributed by nexAir, LLC, 1350 Concourse Ave., Suite 103, Memphis, TN 38104helium 2025

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12213-710
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM999 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12213-710-60113 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    2NDC:12213-710-13408 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    3NDC:12213-710-40425 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    4NDC:12213-710-58586 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    5NDC:12213-710-502067 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    6NDC:12213-710-126145 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    7NDC:12213-710-206201 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    8NDC:12213-710-218240 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    9NDC:12213-710-221019 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20903306/01/1996
    Labeler - NexAir, LLC (927024422)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXAIR, LLC010263301manufacture(12213-710)
    Establishment
    NameAddressID/FEIBusiness Operations
    NexAir, LLC927024422manufacture(12213-710)
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