Label: NITROUS OXIDE - nitrous oxide gas

  • NDC Code(s): 53440-003-01, 53440-003-02, 53440-003-03, 53440-003-04, view more
    53440-003-05
  • Packager: WestAir Gases & Equipment, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

Drug Label Information

Updated 10/12

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE

             USP

    UN 1070    Rx ONLY

    WestAir                                      2506 Market Street

    Gases and Equipment, Inc.          San Diego, Ca. 92102

    NON-FLAMMABLE 2 / OXIDIZER 5.1

    WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND

    THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT. CALL 1-866-231-1366 FOR MORE COPIES.

    2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

    WARNING: HIGH PRESSURE OXIDIZING LIQUID AND GAS. VIGOROUSLY ACCELERATES

    COMBUSTION. CAN CAUSE RAPID SUFFOCATION AND DEATH WITHOUT WARNING (DUE TO OXYGEN

    DEFICIENCY). CAN CAUSE NERVOUSE SYSTEM INJURY AND EMBRYOPETAL TOXICITY. Avoid breathing

    gas. Secure cylinder and provide adequate ventilation in storage and use. Keep oil and grease away. No

    smoking in cylinder area. Do not use or store near  heat or open flame. Use only with equipment cleaned for

    oxygen service and rated for cylinder pressure. Do not get liquid in the eyes, on the skin or clothing. Cylinder temperature

    should not exceed 125 degrees F (52 degrees C). Open valve slowly. Close valve after each use and when empty. Return with at

    least 25 PSIG pressure. Use in accordance with Material Safety Data Sheet. NOTE: Suck-back into cylinder may cause rupture.

    Always use a back-flow preventive device in the piping. 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.3

    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 with 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. CAUTION: Federal law prohibits dispensing without a prescription. CAUTION: USE NO OIL ON VALVE OR

    CONNECTIONS.TRANSFILLING OF THIS GAS IS PROHIBITED. DO NOT REMOVE THIS PRODUCT LABEL.Nitrous Oxide

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53440-003
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Nitrous Oxide (Nitrous Oxide) Nitrous Oxide 995 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53440-003-01 13815 L in 1 CYLINDER
    2 NDC:53440-003-02 7400 L in 1 CYLINDER
    3 NDC:53440-003-03 4934 L in 1 CYLINDER
    4 NDC:53440-003-04 1653 L in 1 CYLINDER
    5 NDC:53440-003-05 863 L in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 01/01/2000
    Labeler - WestAir Gases & Equipment, Inc. (052834694)
    Establishment
    Name Address ID/FEI Business Operations
    WestAir Gases & Equipment 126891717 manufacture(53440-003)
    Establishment
    Name Address ID/FEI Business Operations
    WestAir Gases & Equipment, Inc 140627543 manufacture(53440-003)
    Establishment
    Name Address ID/FEI Business Operations
    WestAir Gases & Equipment, Inc. 014076344 manufacture(53440-003)
    Establishment
    Name Address ID/FEI Business Operations
    WestAir Gases & Equipment 027457687 manufacture(53440-003)
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