Label: HELIUM gas

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

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Drug Label Information

Updated May 25, 2010

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  • PRINCIPAL DISPLAY PANEL

    HELIUM, COMPRESSED U.S.P.
    NON-FLAMMABLE GAS 2           
    WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. 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. Use in accordance with the MSDS and the precautions recommended by the supplier. DO NOT REMOVE THIS PRODUCT LABEL. GT INDUSTRIES 800 RAVIA RD. SULPHUR, LA 70663 PH# 318-583-9278 EMERGENCY PHONE 1-800-641-4357helium

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61095-300
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61095-300-01622 L in 1 CYLINDER
    2NDC:61095-300-02368 L in 1 CYLINDER
    3NDC:61095-300-03651 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1994
    Labeler - GT Industries Inc (844779546)
    Establishment
    NameAddressID/FEIBusiness Operations
    GT Industries Inc844779546manufacture
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