Label: NITROUS OXIDE gas

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

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Drug Label Information

Updated December 3, 2010

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  • PRINCIPAL DISPLAY PANEL

    LifeGas
    NITROUS OXIDE UN1070
    USP CAS: 10024-97-2
    Distributed by: Linde Linde Gas North America LLC 575 Mountain Ave. Murray Hill, NJ 07974
    NON-FLAMMABLE GAS 2      OXIDIZER  5.1   
    MEDICAL GAS
    Rx only. WARNING:  Administration of Nitrous Oxide 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 Nitrous Oxide 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. When used as a diluent for oxygen to produce respirable mixtures, user must assure sufficient oxygen concentration to sustain life.
    WARNING: HIGH PRESSURE OXIDIZING LIQUID AND GAS. CAN CAUSE RAPID SUFFOCATION. MAY CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE. For liquid withdrawal, wear protective equipment to prevent getting liquid in eyes, on skin or clothing. Keep away from heat, flame or sparks. Keep oil, grease and other combustibles away. Transport, store and use with adequate ventilation. Do not strike arc or laser beam on cylinder. Use equipment cleaned for Oxygen service and rated for cylinder pressure. . Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52C (125F). Always secure cylinder in upright position. Use in accordance with the Material Safety Data Sheets for this product, available at Web Site: www.lindeus.com. Close valve after each use and when empty. Return cylinder with 25 psig pressure and cylinder cap secured, if applicable. Open valve slowly.
    FIRST AID: IN CASE OF FROSTBITE, obtain medical treatment immediately.
     IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
    DO NOT REMOVE THIS LABEL.
    LG040C (R 02/08)  L and SP 7468nitrous oxide one

  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP UN1070
    NON-FLAMMABLE GAS 2      OXIDIZER  5.1   37736 (06/05)
    Rx only. WARNING:  Administration of Nitrous Oxide 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 Nitrous Oxide 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: HIGH PRESSURE OXIDIZING LIQUID AND GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION. CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE. Avoid breathing gas. Store and use with adequate ventilation.  Keep oil and grease away. Use only with equipment cleaned for oxygen and rated for cylinder pressure. Do not get liquid in eyes, on skin, or clothing. Cylinder temperature should not exceed 52C (125F). Open valve slowly. Close valve after each use and when empty. Use a back flow preventive device in the piping. 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 physician. IN CASE OF FROSTBITE, obtain medical treatment immediately.
    CAS: 10024-97-2
    DO NOT REMOVE THIS PRODUCT LABEL.
    Cylinders must be refilled by:
    Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
    CONTENTS:  LTRS.     CU. FT.nitrous oxide two

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48883-004
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Nitrous Oxide (UNII: K50XQU1029) (Nitrous Oxide - UNII:K50XQU1029) Nitrous Oxide990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48883-004-01148 L in 1 CYLINDER
    2NDC:48883-004-02936 L in 1 CYLINDER
    3NDC:48883-004-03991 L in 1 CYLINDER
    4NDC:48883-004-041577 L in 1 CYLINDER
    5NDC:48883-004-051726 L in 1 CYLINDER
    6NDC:48883-004-062464 L in 1 CYLINDER
    7NDC:48883-004-074927 L in 1 CYLINDER
    8NDC:48883-004-087386 L in 1 CYLINDER
    9NDC:48883-004-097391 L in 1 CYLINDER
    10NDC:48883-004-1012318 L in 1 DEWAR
    11NDC:48883-004-1113810 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/02/2008
    Labeler - Encompass Medical & Specialty Gases, Ltd. (963344143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963344143manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963719286manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963719096manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Encompass Medical & Specialty Gases, Ltd.963718361manufacture