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FDA Drug information

Carbon Dioxide Nitrogen

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20231010

Version

9

Spl Product Data Elements

Carbon Dioxide Nitrogen Carbon Dioxide Nitrogen NITROGEN CARBON DIOXIDE CARBON DIOXIDE

Application Number

NDA205764

Brand Name

Carbon Dioxide Nitrogen

Generic Name

Carbon Dioxide Nitrogen

Product Ndc

51887-302

Product Type

HUMAN PRESCRIPTION DRUG

Route

RESPIRATORY (INHALATION)

Package Label Principal Display Panel

MAINE OXY SPEC-AIR SPECIALTY GASES NON-FLAMMABLE GAS 2 Compressed Gas, n.o.s. (Carbon Dioxide, Nitrogen) UN1956 Medical Gas Mixture 20% Carbon Dioxide, USP CAS: 124-38-9 Balance Nitrogen, USP CAS: 7727-37-9 Rx only WARNING: Administration of this gas mixture 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 gas mixtures 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: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY INCREASE RESPIRATION AND HEART RATE. 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. 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 Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. DO NOT REMOVE THIS PRODUCT LABEL For Medical Use Only. Ver. 3.67 Lot No.: Lot# - Volume: 5600 Serial # MAINE OXY 22 ALBISTON WAY . AUBURN, ME 04210 . 207-784-5788 carbon dioxide nitrogen mix one

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