Label: HELIOX gas

  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated December 19, 2012

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    OXYGEN 2 NON-FLAMMABLE GAS 2 Compressed Gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Medical Gas Mixture 25% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7740-59-7 CAUTION: Federal law prohibits dispensing without a prescription. Rx Only. WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinde pressure. Store and use with adequate ventilation. Close valve after each use and when empty. Open valve slowly. Administration of this gas mixture 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 gas mixtures 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 appropriate MSDS for each mixture component. Secure cylinder while in transportation, storage, and in use. Serial Number: 283751 In Emergency Call: 1-800-494-9300 Lot No: 338sci12dp1 Volume 25 Exp Date: 12/11/17 Label #: RG101 December 12, 2012 Ver 2.33 For Medical Use Only. Spec Connection International Inc 37325 sr 54 Zephyrhills, FL 33542 Ph# 813-997-8950
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    heliox gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54776-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen300 mL  in 1 L
    Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium700 mL  in 1 L
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54776-001-01707 L in 1 CYLINDER
    2NDC:54776-001-025663 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/2013
    Labeler - Spec Connection International Inc (059854468)
    NameAddressID/FEIBusiness Operations
    Spec Connection International, Inc.026151816manufacture(54776-001)