HELIUM - helium gas 
Encompass Medical & Specialty Gases, Ltd.

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 Label

HELIUM COMPRESSED, USP UN1046
NON-FLAMMABLE GAS  2    37580 (R 06/05)
Rx only. WARNING: Administration of Helium may be hazardous or contraindicated. For use only by or under 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: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). Inhaling Helium to alter the voice may prove fatal and should not be permitted. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  CAS: 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinders must be refilled by:
Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
CONTENTS:  LTRS    CU. FT.Helium Label 1

HELIUM 
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48883-006
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48883-006-0191 L in 1 CYLINDER
2NDC:48883-006-02144 L in 1 CYLINDER
3NDC:48883-006-03377 L in 1 CYLINDER
4NDC:48883-006-04624 L in 1 CYLINDER
5NDC:48883-006-053101 L in 1 CYLINDER
6NDC:48883-006-066201 L in 1 CYLINDER
7NDC:48883-006-078143 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas04/15/2009
Labeler - Encompass Medical & Specialty Gases, Ltd. (963344143)
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases, Ltd.963344143manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases, Ltd.963719286manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases, Ltd.963719096manufacture
Establishment
NameAddressID/FEIBusiness Operations
Encompass Medical & Specialty Gases, Ltd.963718361manufacture

Revised: 12/2010
Document Id: 6c805a0d-190e-4913-8773-189291f0161d
Set id: a7a73da7-a15b-4216-b4a7-c24fcafd201f
Version: 2
Effective Time: 20101220
 
Encompass Medical & Specialty Gases, Ltd.