HELIUM - helium gas 
Air Liquide Healthcare America Corporation

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


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WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT.  CALL 1-800-231-1366 FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

WARNING: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION AND DEATH WITHOUT WARNING.  DO NOT BREATH.  Secure cylinder and provide adequate ventilation in storage and use.  Use only with equipment rated for cylinder pressure.  Cylinder temperature should not exceed 125°F (52°C).  Close valve after each use and when empty.  Return with at least 25 PSIG pressure.  Use in accordance with Material Safety Data Sheet.

FIRST AID:  IF INHALED, remove to fresh air.  If not breathing, give artificial respiration.  If breathing is difficult, give oxygen.  Call a physician.

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.

CAUTION: Federal law prohibits dispensing without prescription.  

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.  TRANSFILLING OF THIS GAS IS PROHIBITED.

DO NOT REMOVE THIS PRODUCT LABEL.
HELIUM 
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64735-030
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:64735-030-01198 L in 1 CYLINDER
2NDC:64735-030-02255 L in 1 CYLINDER
3NDC:64735-030-04708 L in 1 CYLINDER
4NDC:64735-030-206514 L in 1 CYLINDER
5NDC:64735-030-217108 L in 1 CYLINDER
6NDC:64735-030-2237212 L in 1 CYLINDER
7NDC:64735-030-2342650 L in 1 CYLINDER
8NDC:64735-030-257533 L in 1 CYLINDER
9NDC:64735-030-268609 L in 1 CYLINDER
10NDC:64735-030-279544 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1960
Labeler - Air Liquide Healthcare America Corporation (087757167)
Establishment
NameAddressID/FEIBusiness Operations
Air Liquide Healthcare America Corporation067631762manufacture

Revised: 6/2010
 
Air Liquide Healthcare America Corporation