Label: NITROUS OXIDE gas

  • NDC Code(s): 22557-003-01, 22557-003-02, 22557-003-03, 22557-003-04, view more
    22557-003-05
  • Packager: AGP LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 31, 2024

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  • 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. Wear protective gloves, protective clothing, and either eye or face protection. In case of fire: Stop leak if safe to do so. Store locked up. Dispose of contents/container in accordance with container supplier/owner instructions. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Use a back flow preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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.

    CONTENTS:

    LTRS:

    CU.FT.

    AGP AMERICAN GAS PRODUCTS

    An Air Water Company

    15 Sharpners Pond Rd

    Building G

    North Andover, MA 01845

    617-381-1020 nitrous oxide

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:22557-003
    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:22557-003-01265 L in 1 CAN; Type 0: Not a Combination Product02/15/2024
    2NDC:22557-003-0218600 L in 1 CYLINDER; Type 0: Not a Combination Product02/15/2024
    3NDC:22557-003-0314163 L in 1 CYLINDER; Type 0: Not a Combination Product02/15/2024
    4NDC:22557-003-045167 L in 1 CYLINDER; Type 0: Not a Combination Product02/15/2024
    5NDC:22557-003-05711 L in 1 CYLINDER; Type 0: Not a Combination Product02/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20600902/15/2024
    Labeler - AGP LLC (027688717)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGP LLC027688717manufacture(22557-003)