Label: HELIUM gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated June 14, 2010

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  • PRINCIPAL DISPLAY PANEL

    HELIUM, COMPRESSED USP
    UN 1046
    DO NOT REMOVE THIS PRODUCT LABEL
    RX ONLY. CAUTION: Federal law prohibits dispensing without prescription. WARNING: Administration of Helium may be hazardous or contraindicated. For use only by or under supervision of a licensed practitioner who is experienced in the use and administration of Helium and is familiar with the indications, effects, dosage, methods, and frequency and duration of administration, and with the hazards, contraindications. And side effects and the precautions to be taken. CAUTION: HIGH PRESSURE GAS, CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use equipment rated for cylinder pressure. Use a back flow preventative device in the piping. Cylinder temperatures should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheets (MSDS) FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult give oxygen. Call a physican. CAS 7440-59-Airgas
    helium
  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58789-005
    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:58789-005-0199 L in 1 CYLINDER
    2NDC:58789-005-02181 L in 1 CYLINDER
    3NDC:58789-005-03408 L in 1 CYLINDER
    4NDC:58789-005-04666 L in 1 CYLINDER
    5NDC:58789-005-056202 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1965
    Labeler - Airgas Northern California and Nevada, Inc. (029040441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas Northern California and Nevada, Inc.155929755manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas Northern California and Nevada, Inc.946304797manufacture