HELIUM - helium gas 
Linde Gas North America LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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HELIUM, COMPRESSED

       

Label 1

HELIUM, COMPRESSED

UN1046

USP

NON-FLAMMABLE GAS 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. When used as a diluent for oxygen to produce respirable mixtures, user must assure sufficient oxygen concentration to sustain life.

CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION. Open valve slowly and close after each use. Keep away from heat, flame or sparks. Do not strike arc or laser beam on cylinder. Transport, store, and use with adequate ventilation. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52°C (125°F). Always secure cylinder in upright position. Return cylinder with 25 psig pressure. Return cylinder with cylinder cap secured, if applicable. Use this product in accordance with it's specific Material Safety Data Sheet, available at Web Site: www.lindeus.com. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is is difficult, give oxygen. Call a physician.

DO NOT REMOVE THIS PRODUCT LABEL.

CONTENTS:
Cylinder
Type
Liters  
K5688[_]
M2830[_]
_____________________

Distributed by:
Linde Gas North America LLC
Linde
575 Mountain Ave.
Murray Hill, NJ 07974

CAS 7440-59-7

L&SP 4014 MG006D

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. When used as a diluent for oxygen to produce respirable mixtures, user must assure sufficient oxygen concentration to sustain life.

HELIUM  
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:25373-010
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (Helium) Helium99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25373-010-045688 L in 1 CYLINDER
2NDC:25373-010-052830 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas11/27/1990
Labeler - Linde Gas North America LLC (805568339)
Registrant - Linde Gas North America LLC (805568339)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas North America LLC010263301MANUFACTURE(25373-010)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas North America LLC016271697MANUFACTURE(25373-010)

Revised: 1/2014
 
Linde Gas North America LLC