Label: HELIUM gas
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NDC Code(s):
11054-004-01,
11054-004-02,
11054-004-03,
11054-004-04, view more11054-004-05, 11054-004-06, 11054-004-07, 11054-004-08, 11054-004-09, 11054-004-10, 11054-004-11, 11054-004-12, 11054-004-13, 11054-004-14, 11054-004-15, 11054-004-16, 11054-004-17, 11054-004-18, 11054-004-19, 11054-004-20, 11054-004-21, 11054-004-22, 11054-004-23, 11054-004-24, 11054-004-25, 11054-004-26, 11054-004-27, 11054-004-28, 11054-004-29, 11054-004-30, 11054-004-31, 11054-004-32, 11054-004-33, 11054-004-34, 11054-004-35, 11054-004-36, 11054-004-37, 11054-004-38, 11054-004-39, 11054-004-40, 11054-004-41, 11054-004-42, 11054-004-43
- Packager: AIRGAS USA, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 5, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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HELIUM COMPRESSED USP SL
HELIUM,
COMPRESSED
USP
UN1046
DO NOT REMOVE THIS PRODUCT LABEL
NON-FLAMMABLE GAS 2
836580 (07/16)
WARNING: CONTAINS GAS UNDER PRESSURE. MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. INHALING HELIUM TO ALTER THE VOICE CAN BE FATAL. Use and store only outdoors or in a well ventilated place. Protect from sunlight when the ambient temperature exceeds 52°C/125°F. Use only with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortabe for breathing. Get medical advice/attention.
Rx only
WARNING: Administration of Helium 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 Helium 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.
CAS: 7440-59-7
AIRGAS HEALTHCARE
an Air Liquide Company
AIRGAS USA, LLC
Radnor, PA 19087-5283Safety Data Sheets available at www.airgas.com
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HELIUM COMPRESSED USP body label
HELIUM,
COMPRESSED
USP
UN1046
NON-FLAMMABLE GAS 2
Rx only
WARNING: Administration of Helium 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 Helium 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. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. INHALING HELIUM TO ALTER THE VOICE CAN BE FATAL.
Use and store only outdoors or in a well ventilated place. Protect from sunlight when the ambient temperature exceeds 52°C/125°F. Use only with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortabe for breathing. Get medical advice/attention.
CAS: 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL
AIRGAS HEALTHCARE
an Air Liquide Company
AIRGAS USA, LLC
Radnor, PA 19087-5283Safety Data Sheets available at www.airgas.com
Form 850301 (R 06/16)
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11054-004 Route of Administration RESPIRATORY (INHALATION), INTRACORONARY Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 992 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11054-004-01 99 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 2 NDC:11054-004-02 148 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 3 NDC:11054-004-03 144 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 4 NDC:11054-004-04 181 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 5 NDC:11054-004-05 215 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 6 NDC:11054-004-06 359 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 7 NDC:11054-004-07 448 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 8 NDC:11054-004-08 566 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 9 NDC:11054-004-09 590 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 10 NDC:11054-004-10 1508 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 11 NDC:11054-004-11 3022 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 12 NDC:11054-004-12 177 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 13 NDC:11054-004-13 183 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 14 NDC:11054-004-14 204 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 15 NDC:11054-004-15 354 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 16 NDC:11054-004-16 367 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 17 NDC:11054-004-17 408 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 18 NDC:11054-004-18 459 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 19 NDC:11054-004-19 511 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 20 NDC:11054-004-20 577 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 21 NDC:11054-004-21 598 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 22 NDC:11054-004-22 666 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 23 NDC:11054-004-23 1021 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 24 NDC:11054-004-24 1137 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 25 NDC:11054-004-25 1397 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 26 NDC:11054-004-26 1555 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 27 NDC:11054-004-27 2105 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 28 NDC:11054-004-28 2344 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 29 NDC:11054-004-29 2835 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 30 NDC:11054-004-30 3120 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 31 NDC:11054-004-31 3460 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 32 NDC:11054-004-32 3853 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 33 NDC:11054-004-33 4762 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 34 NDC:11054-004-34 5664 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 35 NDC:11054-004-35 6570 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 36 NDC:11054-004-36 5503 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 37 NDC:11054-004-37 6202 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 38 NDC:11054-004-38 6370 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 39 NDC:11054-004-39 6910 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 40 NDC:11054-004-40 8009 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 41 NDC:11054-004-41 8210 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 42 NDC:11054-004-42 10685 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 43 NDC:11054-004-43 10860 L in 1 CYLINDER; Type 0: Not a Combination Product 11/06/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205843 11/06/1997 Labeler - AIRGAS USA, LLC (078301808) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 049375921 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 003324498 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 032547507 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 947401071 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 827455648 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 879945632 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 006301766 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 062187120 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 023681450 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 827455879 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 946304797 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 168167799 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 833002111 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 072198059 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 620137799 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 079214355 manufacture(11054-004) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 079934743 manufacture(11054-004)