Helium by Keen Compressed Gas Co. Inc. / Keen Compressed Gas Company, Inc. HELIUM gas

Helium by

Drug Labeling and Warnings

Helium by is a Prescription medication manufactured, distributed, or labeled by Keen Compressed Gas Co. Inc., Keen Compressed Gas Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED USP

UN1046

Rx only. WARNING: Administration of Helium USP 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 USP 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. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). 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: 7740-59-7 DO NOT REMOVE THIS PRODUCT LABEL.

Manufactured by:

KEEN COMPRESSED GAS CO

4063 New Castle Ave. New Castle, DE 19720

(302) 594-4545

INGREDIENTS AND APPEARANCE

HELIUM 
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48273-011
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48273-011-01	424.75 L in 1 CYLINDER; Type 0: Not a Combination Product	06/11/2019
2	NDC: 48273-011-02	707.92 L in 1 CYLINDER; Type 0: Not a Combination Product	06/11/2019
3	NDC: 48273-011-03	6201.39 L in 1 CYLINDER; Type 0: Not a Combination Product	06/11/2019
4	NDC: 48273-011-04	5663.37 L in 1 CYLINDER; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA206826	06/11/2019

Labeler - Keen Compressed Gas Co. Inc. (002484723)

Establishment
Name	Address	ID/FEI	Business Operations
Keen Compressed Gas Company, Inc.		617860770	manufacture(48273-011)