Label: HELIUM- helium gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-010-04, 25373-010-05, 25373-010-06, 25373-010-07, view more25373-010-08, 25373-010-09 - Packager: Linde Gas & Equipment Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2021
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WARNINGS SECTION
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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.
Linde
HELIUM, COMPRESSED USP
UN1046
CAS 7440-59-7
Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427
MEDICAL GAS
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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.
WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPACE OXYGEN AND CAUSE RAPID SUFFOCATION.
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 rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
DO NOT REMOVE THIS LABEL.
CONTENTS: Cylinder Type Liters K 5888 [_] M 2830 [_] M4 96 [_] D 374 [_] E 577 [_] ______ ______ ______ MG150B
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HELIUM, COMPRESSED
USP
UN1046
CAS 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL.
2
MEDICAL GAS
Rx only
Linde
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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.
CAUTION: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPACE OXYGEN AND CAUSE RAPID SUFFOCATION. 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 rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.CONTENTS: Cylinder
TypeLiters K 5688 [_] M 2830 [_] _______ _______ _______ Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427
MG006G
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25373-010 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25373-010-04 5688 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 2 NDC:25373-010-05 2830 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 3 NDC:25373-010-06 5888 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 4 NDC:25373-010-07 96 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 5 NDC:25373-010-08 374 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 6 NDC:25373-010-09 577 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206826 11/27/1990 Labeler - Linde Gas & Equipment Inc. (805568339) Registrant - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 010263301 manufacture(25373-010) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016271697 manufacture(25373-010)