HELIUM - helium gas 
Praxair Distribution, Inc.

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

UN1046 HELIUM, COMPRESSED USP CONTENTS LOT NUMBER CAUTION! HIGH-PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. MAY CAUSE DIZZINESS AND DROWSINESS. Store and use with adequate ventilation. Use with equipment rated for cylinder pressure. Use a backflow prevention device in any piping. Cylinder temperature should not exceed 125°F (52°C). Close valve after each use; keep closed even when empty. Always secure cylinder. Install cap, if provided, when not in use per Praxair MSDS form P-4602 and safe practices booklets P-3499 and P-14-153; obtain from your local supplier. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, qualified personnel may 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. IN CASE OF EMERGENCY: CALL 1-800-645-4633 CAS: 7440-59-7 2 Rx ONLY DISTRIBUTED BY PRAXAIR, INC., DANBURY DO NOT REMOVE THIS LABEL PMG-3 (07/08) Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113
Helium one
HELIUM 
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59579-005
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (Helium) Helium990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59579-005-0114696 L in 1 CYLINDER
2NDC:59579-005-0212233 L in 1 CYLINDER
3NDC:59579-005-039430 L in 1 CYLINDER
4NDC:59579-005-048240 L in 1 CYLINDER
5NDC:59579-005-056909 L in 1 CYLINDER
6NDC:59579-005-066173 L in 1 CYLINDER
7NDC:59579-005-073823 L in 1 CYLINDER
8NDC:59579-005-083087 L in 1 CYLINDER
9NDC:59579-005-092067 L in 1 CYLINDER
10NDC:59579-005-101048 L in 1 CYLINDER
11NDC:59579-005-11623 L in 1 CYLINDER
12NDC:59579-005-12510 L in 1 CYLINDER
13NDC:59579-005-15368 L in 1 CYLINDER
14NDC:59579-005-16113 L in 1 CYLINDER
15NDC:59579-005-17170 L in 1 CYLINDER
16NDC:59579-005-186768 L in 1 CYLINDER
17NDC:59579-005-192209 L in 1 CYLINDER
18NDC:59579-005-20821 L in 1 CYLINDER
19NDC:59579-005-13538 L in 1 CYLINDER
20NDC:59579-005-14142 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas12/01/2007
Labeler - Praxair Distribution, Inc. (042845636)
Establishment
NameAddressID/FEIBusiness Operations
Praxair Distribution, Inc161317490manufacture(59579-005)
Establishment
NameAddressID/FEIBusiness Operations
Praxair Distribution, Inc.045252439manufacture(59579-005)
Establishment
NameAddressID/FEIBusiness Operations
Praxair Distribution, Inc.159890391manufacture(59579-005)
Establishment
NameAddressID/FEIBusiness Operations
Praxair Distribution, Inc.049964372manufacture(59579-005)
Establishment
NameAddressID/FEIBusiness Operations
Praxair Distribution, Inc.027514424manufacture(59579-005)

Revised: 11/2012
 
Praxair Distribution, Inc.