Label: NITROUS OXIDE gas

  • NDC Code(s): 44076-012-01, 44076-012-02, 44076-012-03, 44076-012-04, view more
    44076-012-05, 44076-012-06, 44076-012-07, 44076-012-08, 44076-012-09, 44076-012-10, 44076-012-11, 44076-012-12, 44076-012-13, 44076-012-14
  • Packager: American Welding & Gas
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 7, 2024

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

  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP

    UN1070

    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. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Avoid breathing gas. Do not get in eyes, on skin or on clothing. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 10024-97-2 DO NOT REMOVE THIS PRODUCT LABEL.

    AWG

    AMERICAN WELDING AND GAS

    1346 Monad Road, Billings, MT 59101

    406.256.3344 nitrous oxide

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:44076-012
    Route of AdministrationRESPIRATORY (INHALATION)
    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:44076-012-01160 L in 1 DEWAR; Type 0: Not a Combination Product05/01/2014
    2NDC:44076-012-02180 L in 1 DEWAR; Type 0: Not a Combination Product05/01/2014
    3NDC:44076-012-03200 L in 1 DEWAR; Type 0: Not a Combination Product05/01/2014
    4NDC:44076-012-04230 L in 1 DEWAR; Type 0: Not a Combination Product05/01/2014
    5NDC:44076-012-05265 L in 1 DEWAR; Type 0: Not a Combination Product05/01/2014
    6NDC:44076-012-06566 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    7NDC:44076-012-071132 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    8NDC:44076-012-081557 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    9NDC:44076-012-092265 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    10NDC:44076-012-103114 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    11NDC:44076-012-113539 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    12NDC:44076-012-126229 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    13NDC:44076-012-137079 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    14NDC:44076-012-148495 L in 1 CYLINDER; Type 0: Not a Combination Product05/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20570405/01/2014
    Labeler - American Welding & Gas (068181965)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN WELDING & GAS, INC.116724243manufacture(44076-012)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Welding & Gas, Inc.829720098manufacture(44076-012)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Welding & Gas, Inc. dba Coastal Welding Supply & Specialty Gas119024311manufacture(44076-012)