Label: HELIUM gas

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 23, 2010

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

  • PRINCIPAL DISPLAY PANEL

    HELIUM, COMPRESSED USP            UN1046
    DO NOT REMOVE THIS PRODUCT LABEL.  NON-FLAMMABLE GAS  2            836580 (12/04)
    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, dosages, 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 preventive 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 Sheet (MSDS). Inhaling Helium to alter the voice may prove fatal and should not be permitted. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.    CAS: 7440-59-7

    AIRGAS PURITAN MEDICAL     AIRGAS EAST, Inc.  Salem, NH  03079 (800) 562-3815helium

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25543-011
    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:25543-011-01300 L in 1 CYLINDER
    2NDC:25543-011-02500 L in 1 CYLINDER
    3NDC:25543-011-033100 L in 1 CYLINDER
    4NDC:25543-011-046910 L in 1 CYLINDER
    5NDC:25543-011-058240 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas02/17/1998
    Labeler - Airgas East, Inc. (606601136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.059164256manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.003249885manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.055380963manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.046287736manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.105767565manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.969097807manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.052983954manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827450383manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.604082982manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.003404654manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.002239812manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.053648705manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.959842725manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.606601136manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.783063886manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.073503257manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.619057839manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.884477043manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.788119894manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620138292manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.556180615manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620137799manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.020083242manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620137955manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620137963manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620138698manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620139068manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.788120074manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.003091907manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.085613073manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455614manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455630manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455549manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.824717347manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455598manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.066986654manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455622manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.825047686manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620138821manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.827455523manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.018961656manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.184696177manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Airgas East, Inc.620138730manufacture