Label: HELIUM, OXYGEN gas
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NDC Code(s):
11054-041-01,
11054-041-02,
11054-041-03,
11054-041-04, view more11054-041-05
- Packager: AIRGAS USA, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated October 5, 2023
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S.
(80% HELIUM USP, 20% OXYGEN USP)
UN1956
NON-FLAMMABLE GAS 2
837137 (02/17)
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 preventative 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 52oC/125oF. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Seek medical advice/attention. CAS HELIUM 7440-59-7 OXYGEN 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL
Airgas, Healthcare
An Air Liquide Company
AIRGAS USA, LLC
Radnor, PA 19087-5283
Safety Data Sheets available at www. airgas.com
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INGREDIENTS AND APPEARANCE
HELIUM, OXYGEN
helium, oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11054-041 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 800 mL in 1 L OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 200 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11054-041-01 300 L in 1 CYLINDER; Type 0: Not a Combination Product 10/14/1997 2 NDC:11054-041-02 500 L in 1 CYLINDER; Type 0: Not a Combination Product 10/14/1997 3 NDC:11054-041-03 2260 L in 1 CYLINDER; Type 0: Not a Combination Product 10/14/1997 4 NDC:11054-041-04 4000 L in 1 CYLINDER; Type 0: Not a Combination Product 10/14/1997 5 NDC:11054-041-05 4500 L in 1 CYLINDER; Type 0: Not a Combination Product 10/14/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA205843 10/14/1997 Labeler - AIRGAS USA, LLC (078301808) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 003324498 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 006301766 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 032547507 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 072198059 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 079214355 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 079934743 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 620137799 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 790441885 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 827455879 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 879945632 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 946304797 manufacture(11054-041) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 947401071 manufacture(11054-041)