HELIUM- helium gas 
Keen Compressed Gas Co. Inc.

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Helium

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 helium

HELIUM 
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:48273-011
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:48273-011-01424.75 L in 1 CYLINDER; Type 0: Not a Combination Product06/11/2019
2NDC:48273-011-02707.92 L in 1 CYLINDER; Type 0: Not a Combination Product06/11/2019
3NDC:48273-011-036201.39 L in 1 CYLINDER; Type 0: Not a Combination Product06/11/2019
4NDC:48273-011-045663.37 L in 1 CYLINDER; Type 0: Not a Combination Product06/11/2019
5NDC:48273-011-05226 L in 1 CYLINDER; Type 0: Not a Combination Product06/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20682606/11/2019
Labeler - Keen Compressed Gas Co. Inc. (002484723)
Establishment
NameAddressID/FEIBusiness Operations
Keen Compressed Gas Company, Inc.617860770manufacture(48273-011)

Revised: 10/2023
Document Id: 07617bf4-1bf4-c8a7-e063-6294a90a485b
Set id: 8bb1e27a-6855-a7c1-e053-2995a90a261e
Version: 7
Effective Time: 20231010
 
Keen Compressed Gas Co. Inc.