Carbon Dioxide Oxygen Mixture 5/95 Gas
FDA Label NDC 17575-020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agl Inhalation Therapy Co. for the product Carbon Dioxide Oxygen Mixture 5/95 (NDC 17575-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

AGL Certified ISO 9001:2008 Inhalation Therapy Co. CLIFTON, NJ 07015 973-478-5100
NON-FLAMMABLE GAS 2 OXYDIZER 5.1
Compressed gas, oxidizing, n.o.s. (Carbon Dioxide, Oxygen) UN3156 Medical Gas Mixture 5% Carbon Dioxide, USP CAS: 124-38-9 95% Oxygen, USP CAS: 7782-44-7
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 CAUSE OR INTENSIFY FIRE; OXIDIZER. 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. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet before use. FIRST AID: IF ACCIDENTALLY 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. Label # AGL-8-D-124-4 01/21/16 Ver. 3.67 Lot No.: -Volume: Liters AGL 600 Rt. 46 W CLIFTON, N.J., 07015

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

Carbon Dioxide Oxygen Ninety-five Five (Carbondioxideoxygen955)

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