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Dosage Form: gas

Helium COMPRESSED USP sl

Helium,

COMPRESSED

USP

UN1046

DO NOT REMOVE THIS PRODUCT LABEL

NON-FLAMMABLE GAS 2

836580 (10/14)

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 Puritan Medical®

AIRGAS USA, LLC - Radnor, PA 19087-5283

Helium COMPRESSED USP

Helium,

COMPRESSED

USP

UN1046

DO NOT REMOVE THIS PRODUCT LABEL

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 Puritan Medical®

AIRGAS USA, LLC - Radnor, PA 19087-5283

Form 850301 (R 10/14)

Helium 
Helium gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11054-004
Route of Administration RESPIRATORY (INHALATION), INTRACORONARY DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Helium (Helium) Helium 992 mL  in 1 L
Packaging
# Item Code Package Description
1 NDC:11054-004-01 99 L in 1 CYLINDER
2 NDC:11054-004-02 148 L in 1 CYLINDER
3 NDC:11054-004-03 144 L in 1 CYLINDER
4 NDC:11054-004-04 181 L in 1 CYLINDER
5 NDC:11054-004-05 215 L in 1 CYLINDER
6 NDC:11054-004-06 359 L in 1 CYLINDER
7 NDC:11054-004-07 448 L in 1 CYLINDER
8 NDC:11054-004-08 566 L in 1 CYLINDER
9 NDC:11054-004-09 590 L in 1 CYLINDER
10 NDC:11054-004-10 1508 L in 1 CYLINDER
11 NDC:11054-004-11 3022 L in 1 CYLINDER
12 NDC:11054-004-12 177 L in 1 CYLINDER
13 NDC:11054-004-13 183 L in 1 CYLINDER
14 NDC:11054-004-14 204 L in 1 CYLINDER
15 NDC:11054-004-15 354 L in 1 CYLINDER
16 NDC:11054-004-16 367 L in 1 CYLINDER
17 NDC:11054-004-17 408 L in 1 CYLINDER
18 NDC:11054-004-18 459 L in 1 CYLINDER
19 NDC:11054-004-19 511 L in 1 CYLINDER
20 NDC:11054-004-20 577 L in 1 CYLINDER
21 NDC:11054-004-21 598 L in 1 CYLINDER
22 NDC:11054-004-22 666 L in 1 CYLINDER
23 NDC:11054-004-23 1021 L in 1 CYLINDER
24 NDC:11054-004-24 1137 L in 1 CYLINDER
25 NDC:11054-004-25 1397 L in 1 CYLINDER
26 NDC:11054-004-26 1555 L in 1 CYLINDER
27 NDC:11054-004-27 2105 L in 1 CYLINDER
28 NDC:11054-004-28 2344 L in 1 CYLINDER
29 NDC:11054-004-29 2835 L in 1 CYLINDER
30 NDC:11054-004-30 3120 L in 1 CYLINDER
31 NDC:11054-004-31 3460 L in 1 CYLINDER
32 NDC:11054-004-32 3853 L in 1 CYLINDER
33 NDC:11054-004-33 4762 L in 1 CYLINDER
34 NDC:11054-004-34 5664 L in 1 CYLINDER
35 NDC:11054-004-35 6570 L in 1 CYLINDER
36 NDC:11054-004-36 5503 L in 1 CYLINDER
37 NDC:11054-004-37 6202 L in 1 CYLINDER
38 NDC:11054-004-38 6370 L in 1 CYLINDER
39 NDC:11054-004-39 6910 L in 1 CYLINDER
40 NDC:11054-004-40 8009 L in 1 CYLINDER
41 NDC:11054-004-41 8210 L in 1 CYLINDER
42 NDC:11054-004-42 10685 L in 1 CYLINDER
43 NDC:11054-004-43 10860 L in 1 CYLINDER
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 Operations
AIRGAS USA, LLC 829050819 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 800771487 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 961831190 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 003324498 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 032547507 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 827455648 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 017427142 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 790302496 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 062187120 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 113526545 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 602249583 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 833002020 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 833002111 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 620139084 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 620138292 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 620137799 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 037295749 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 828363957 manufacture(11054-004)
Establishment
Name Address ID/FEI Operations
AIRGAS USA, LLC 090327250 manufacture(11054-004)
Revised: 05/2016
 
AIRGAS USA, LLC



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