HELIUM COMPRESSED USP LABEL

Helium
Compressed
USP
UN1046 ((RK-20) XXXXXXR

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. Do not handle until all safety
precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Protect from sunlight when ambient temperature exceeds 52º C (125º F).Use a back flow preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Read
and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep
comfortable for breathing. Get medical advice/attention. CAS 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL

Norco
1125 W. Amity Rd. • Boise, ID 83705
208-336-1643

CONTENTS

LTRS: __

CU.FT. __

helium compressed

res

HELIUM
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42602-002
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	99 L in 100 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42602-002-01	595 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2008
2	NDC:42602-002-02	6202 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2008
3	NDC:42602-002-03	368 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2008
4	NDC:42602-002-04	142 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2008
5	NDC:42602-002-05	1530 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205819	09/01/2008

Labeler - Norco, Inc. (043694645)

Registrant - Norco, Inc. (043694645)

Name	Address	ID/FEI	Business Operations
Establishment
Norco, Inc.		962460528	manufacture(42602-002)