Label: HELIUM gas

  • NDC Code(s): 84120-001-01, 84120-001-02, 84120-001-03, 84120-001-04, view more
    84120-001-05, 84120-001-06, 84120-001-07, 84120-001-08, 84120-001-09, 84120-001-10, 84120-001-11
  • Packager: WSM SUPPLIER LLC.
  • This is a repackaged label.
  • Source NDC Code(s): 11054-004
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 3, 2024

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    HELIUM, COMPRESSED USP

    UN1046

    Rx only. 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. 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. 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. CAS HELIUM 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.

    WSM SUPPLIER LLC

    3535 NW 60th Street

    Miami FL 33142 (305) 455 1220

    www.wsmsupplier.com helium

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:84120-001(NDC:11054-004)
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM992 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84120-001-01377 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    2NDC:84120-001-02623 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    3NDC:84120-001-032143 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    4NDC:84120-001-042899 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    5NDC:84120-001-055689 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    6NDC:84120-001-066201 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    7NDC:84120-001-076338 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    8NDC:84120-001-086824 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    9NDC:84120-001-097481 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    10NDC:84120-001-108144 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    11NDC:84120-001-11762 L in 1 CYLINDER; Type 0: Not a Combination Product05/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584305/07/2024
    Labeler - WSM SUPPLIER LLC. (077254165)
    Establishment
    NameAddressID/FEIBusiness Operations
    WSM SUPPLIER LLC.077254165relabel(84120-001)