Label: HELIUM gas

  • NDC Code(s): 12213-710-12, 12213-710-13, 12213-710-40, 12213-710-50, view more
    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 October 1, 2020

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  • PRINCIPAL DISPLAY PANEL

    HELIUM, COMPRESSED USP

    UN1046

    RX only. 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. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). 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. Rx only. 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 of duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. CAS: 7440-59-7 DO NOT REMOVE THIS PRODUCT LABLE.

    nexAir

    Distributed by nexAir, LLC www.nexAir.com

    1350 Concourse Ave., Suite 103 Memphis, TN 38104

    LOT #

    PART #

    CF. LITERS: helium

  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20585106/01/1996
    Labeler - NexAir, LLC (927024422)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXAIR, LLC010263301manufacture(12213-710)
    Establishment
    NameAddressID/FEIBusiness Operations
    NexAir, LLC927024422manufacture(12213-710)