Label: OXYGEN HELIUM MIXTURE gas
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Contains inactivated NDC Code(s)
NDC Code(s): 10014-009-03, 10014-009-04, 10014-009-05 - Packager: Aero All Gas Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 18, 2017
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S. (80% HELIUM USP, 20% OXYGEN USP) UN1956 NON-FLAMMABLE GAS 2
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. Do not handle until all safety precautions have been read and understood. Avoid breathing gas. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. when Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet.
FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
CAS HELIUM 7440-59-7 OXYGEN 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
ALL-GAS THE AERO ALL-GAS COMPANY 3150 MAIN ST. . HARTFORD, CT 06120 (860) 278-AERO (2376)
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INGREDIENTS AND APPEARANCE
OXYGEN HELIUM MIXTURE
oxygen helium mixture gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10014-009 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:10014-009-03 425 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 2 NDC:10014-009-04 705 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 3 NDC:10014-009-05 7108 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205840 10/06/1972 Labeler - Aero All Gas Company (004532065) Establishment Name Address ID/FEI Business Operations Aero All Gas Company 004532065 repack(10014-009)