Label: OXYGEN/HELIUM 50/50 gas
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Contains inactivated NDC Code(s)
NDC Code(s): 55037-640-01, 55037-640-02, 55037-640-03 - Packager: MATHESON TRI-GAS, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 2, 2022
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PRINCIPAL DISPLAY PANEL
Compressed gas, n.o.s.
(Oxygen, Helium)
UN1956
Medical Gas Mixture
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.
WARNING CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
Do not handle until all safety precautions have been read and understood. 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. 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 (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
Matheson
909 Lake Carolyn Pkwy
Irving, TX 75039
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INGREDIENTS AND APPEARANCE
OXYGEN/HELIUM 50/50
oxygen/helium 50/50 gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55037-640 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 500 mL in 1 L Inactive Ingredients Ingredient Name Strength HELIUM (UNII: 206GF3GB41) 500 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55037-640-01 6010 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1987 2 NDC:55037-640-02 650 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1987 3 NDC:55037-640-03 630 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1987 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205889 01/01/1987 Labeler - MATHESON TRI-GAS, INC. (179092028) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 035676147 manufacture(55037-640) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 045200315 manufacture(55037-640) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 074768669 manufacture(55037-640) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 111249868 manufacture(55037-640) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 606686202 manufacture(55037-640) Establishment Name Address ID/FEI Business Operations MATHESON TRI-GAS, INC. 832779602 manufacture(55037-640)