Label: OXYGEN HELIUM MIXTURE 20/80 gas
- NDC Code(s): 17575-192-01, 17575-192-02, 17575-192-03
- Packager: AGL Inhalation Therapy Co.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 6, 2023
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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. (Oxygen, Helium) UN1956 Part # K2MOH Medical Gas Mixture 20% 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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INGREDIENTS AND APPEARANCE
OXYGEN HELIUM MIXTURE 20/80
oxygen helium mixture 20/80 gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17575-192 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 200 mL in 1 L Inactive Ingredients Ingredient Name Strength HELIUM (UNII: 206GF3GB41) 800 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17575-192-01 4554 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 2 NDC:17575-192-02 500 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 3 NDC:17575-192-03 4910 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 01/01/1966 Labeler - AGL Inhalation Therapy Co. (011186004) Establishment Name Address ID/FEI Business Operations AGL Inhalation Therapy Co. 011186004 manufacture(17575-192)