Label: HELIUM gas
- NDC Code(s): 10014-004-10, 10014-004-11, 10014-004-12, 10014-004-13
- Packager: Aero All Gas Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 7, 2022
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP UN1046 NON-FLAMMABLE GAS 2 Rx Only.
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. 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 degrees C (125 degrees 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 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL CONTENTS: LTRS. CU. FT.
ALL-GAS THE AERO ALL-GAS COMPANY 3150 MAIN ST. . HARTFORD, CT 06120 (860) 278-AERO (2376)
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10014-004 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:10014-004-10 623 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 2 NDC:10014-004-11 3115 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 3 NDC:10014-004-12 6202 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 4 NDC:10014-004-13 7561 L in 1 CYLINDER; Type 0: Not a Combination Product 10/06/1972 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206826 10/06/1972 Labeler - Aero All Gas Company (004532065) Establishment Name Address ID/FEI Business Operations Aero All Gas Company 004532065 manufacture(10014-004)