FDA Label for Oxygen Helium Mixture 30/70

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Oxygen Helium Mixture 30/70 Product Label

The following document was submitted to the FDA by the labeler of this product Agl Inhalation Therapy Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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. (Oxygen, Helium) UN3156 Part # K2MOH Medical Gas Mixture 30% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7440-59-7
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. 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 Volume: 4910 Liters AGL 600 Rt. 46 W CLIFTON, N.J., 07015


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