Label: NITROGEN gas

  • NDC Code(s): 48546-0003-1, 48546-0003-2
  • Packager: Indiana Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 21, 2020

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

  • NITROGEN COMPRESSED LABEL

    NITROGEN, COMPRESSED NF     UN1066

    NON-FLAMMABLE GAS 2              35149 (01/15)

    Rx only. WARNING: Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practioner who is experienced in the use and administration of Nitrogen 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: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE, IF HEATED, MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. 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. Get medical advice/attention. CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL

    INDIANA OXYGEN COMPANY

    6099 WEST CORPORATE WAY • INDIANAPOLIS, IN 46278

    317-290-0003

    Nitrogen Shoulder Label

    Nitrogen Shoulder Label

  • NITROGEN REFRIGERATED LIQUID LABEL

    REFRIGERATED LIQUID

    NITROGEN, REFRIGERATED LIQUID NF UN1977

    NON-FLAMMABLE GAS 2 (R-K14) 115149

    ↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.↑

    DO NOT CHANGE OR FORCE FIT CONNECTIONS.

    RX ONLY

    CONTENTS: ___________________________________ LTRS: ___ CU FT: ___

    WARNING:         Administration of Nitrogen 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 Nitrogen 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:         CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION.

    Do not handle until all safety precautions have been read and understood.

    Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. Use a back-flow preventive device in the piping. DO NOT change or force fit connections.

    Close valve after each use and when empty.

    Always keep container in upright position.

    Read and follow the Safety Data Sheet (SDS) before use.

    FIRST AID:           IF INHALED: Remove person to fresh air and keep comfortable for breathing.

    IF ON SKING: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.

    CAS: 7727-37-9

    DO NOT REMOVE THIS PRODUCT LABEL.

    INDIANA OXYGEN COMPANY

    6099 West Corporate Way

    Indianapolis, IN 46278

    317-290-0003

    Nitrogen LIquid Label

    Nitrogen LIquid Label

  • NITROGEN CERTIFICATE OF ANALYSIS

    Certificate of Analysis - Nitrogen NF Customer ________________________ Vendor / Supplier _____________________________ This letter is to provide you with the certification you requested for Nitrogen NF, Lot number ___________. supplied to you in cylinders / vessels by our location. These cylinders were filled in accordance with the standard operating procedures utilized for the manufacture of Medical Gases. By following these procedures, our location ensures that products are safely manufactured in compliance with FDA's Current Good Manufacturing Regulations. CAUTION: Vendor supplies this certification to customer to assist customer in ensuring compliance with 21 CFR 211.84. This certification does not eliminate customer's obligation to cmply with other portions of 21 CFR 210 and 211 including but not limited to 21 CFR 211.165 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certified for instrument calibration purposes.

    TEST/REQUIREMENT         NF SPECIFICATION             LOT ANALYSIS
    IDENTIFICATION                    PASS
    ODOR                                    NO APPRECIABLE ODOR
    OXYGEN                               LESS THAN 1.0%
    CARBON MONOXIDE             LESS THAN 10 PPM
    ASSAY                                  GREATER THAN 99.0%

    THE METHODOLOGY BEING USED TO PERFORM THE NF TEST FOR ASSAY IS INDICATED BELOW:

    ________________________ PARAMAGNETIC ANALYZER MODEL NUMBER ___________________

    ________________________ ELECTROCHEMICAL ANALYZER MODEL NUMBER ______________

    _______________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

    SUPPLIER SIGNATURE ___________________ DATE _________________

    J 700 a1 (01/03) BR COMPLIANCE ASSOCIATES LLC

    Nitrogen Certificate of Analysis

    Nitrogen Certificate of Analysis

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48546-0003
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48546-0003-16400 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1975
    2NDC:48546-0003-24220 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1975
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576601/01/1975
    Labeler - Indiana Oxygen Company, Inc. (006036776)
    Registrant - Indiana Oxygen Company, Inc. (006036776)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Oxygen Company, Inc.006036776manufacture(48546-0003)