Oxygen Helium Mixture

Dosage Form: gas
Helium Oxygen Mix Label

COMPRESSED GAS , OXIDIZING, N.O.S. (70% HELIUM USP, 30% OXYGEN USP) UN 3156

NON-FLAMMABLE GAS  2    OXIDIZER 5.1

34313 (01/09)     OXYGEN CONTENT OVER 23.5%

Rx only. CAUTION: Federal law prohibits dispensing without prescription. WARNING: Administration of this gas 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 gas mixtures, 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: HIGH PRESSURE OXIDIZING GAS. MAY VIGOROUSLY ACCELERATE COMBUSTION. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). Open valve slowly. Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  HELIUM CAS: 7440-59-7   OXYGEN CAS: 7782-44-7

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 OXYGEN MIX  helium oxygen mix  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48883-007 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (Helium) Helium 500 mL  in 1 L Oxygen (Oxygen) Oxygen 500 mL  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 48883-007-01 617 L In 1 CYLINDER None 2 48883-007-02 623 L In 1 CYLINDER None 3 48883-007-03 629 L In 1 CYLINDER None 4 48883-007-04 640 L In 1 CYLINDER None 5 48883-007-05 654 L In 1 CYLINDER None 6 48883-007-06 5689 L In 1 CYLINDER None 7 48883-007-07 5743 L In 1 CYLINDER None 8 48883-007-08 5796 L In 1 CYLINDER None 9 48883-007-09 5904 L In 1 CYLINDER None 10 48883-007-10 6009 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		04/15/2009

Labeler - Encompass Medical & Specialty Gases Ltd (963344143)

Establishment
Name	Address	ID/FEI	Operations
Encompass Medical & Specialty Gases Ltd		963344143	manufacture

Establishment
Name	Address	ID/FEI	Operations
Encompass Medical & Specialty Gases Ltd		963719286	manufacture

Establishment
Name	Address	ID/FEI	Operations
Encompass Medical & Specialty Gases Ltd		963719096	manufacture

Establishment
Name	Address	ID/FEI	Operations
Encompass Medical & Specialty Gases Ltd		963718361	manufacture

Revised: 12/2011Encompass Medical & Specialty Gases Ltd