Label: HELIUM gas
48273-011-04, view more48273-011-05
- Packager: Keen Compressed Gas Co. Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 17, 2022
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP
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.
KEEN COMPRESSED GAS CO
4063 New Castle Ave. New Castle, DE 19720
INGREDIENTS AND APPEARANCE
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 5 NDC:48273-011-05 226 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)