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FDA Drug information

Carbon Dioxide-Oxygen Mixture

Read time: 1 mins
Marketing start date: 18 Jun 2024

Summary of product characteristics


Effective Time

20231116

Version

5

Spl Product Data Elements

Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture CARBON DIOXIDE CARBON DIOXIDE OXYGEN OXYGEN

Application Number

NDA205849

Brand Name

Carbon Dioxide-Oxygen Mixture

Generic Name

Carbon Dioxide-Oxygen Mixture

Product Ndc

46123-124

Product Type

HUMAN PRESCRIPTION DRUG

Route

RESPIRATORY (INHALATION)

Package Label Principal Display Panel

COMPRESSED GAS, OXIDIZING, N.O.S. (%%%) UN3156 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: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. 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 ACCIDENTALLY INHALED. Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. CAS: ,,,. DO NOT REMOVE THIS PRODUCT LABEL. Roberts Oxygen Company, Inc. PO Box 5507 Rockville, MD 20855 301-948-8100 co2 o2

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