Helium Oxygen Mix by Encompass Medical & Specialty Gases Ltd HELIUM OXYGEN MIX gas

Helium Oxygen Mix by

Drug Labeling and Warnings

Helium Oxygen Mix by is a Prescription medication manufactured, distributed, or labeled by Encompass Medical & Specialty Gases Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

HELIUM OXYGEN MIX 
helium oxygen mix gas

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41)	Helium	500 mL  in 1 L
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)	Oxygen	500 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48883-007-01	617 L in 1 CYLINDER
2	NDC: 48883-007-02	623 L in 1 CYLINDER
3	NDC: 48883-007-03	629 L in 1 CYLINDER
4	NDC: 48883-007-04	640 L in 1 CYLINDER
5	NDC: 48883-007-05	654 L in 1 CYLINDER
6	NDC: 48883-007-06	5689 L in 1 CYLINDER
7	NDC: 48883-007-07	5743 L in 1 CYLINDER
8	NDC: 48883-007-08	5796 L in 1 CYLINDER
9	NDC: 48883-007-09	5904 L in 1 CYLINDER
10	NDC: 48883-007-10	6009 L in 1 CYLINDER

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	Business Operations
Encompass Medical & Specialty Gases Ltd		963344143	manufacture

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

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

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