Label: HELIUM gas
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NDC Code(s):
12213-710-12,
12213-710-13,
12213-710-20,
12213-710-21, view more12213-710-22, 12213-710-40, 12213-710-50, 12213-710-58, 12213-710-60
- Packager: NexAir, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 16, 2023
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP
UN1046
RX only. 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. Rx only. 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 of duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. CAS: 7440-59-7 DO NOT REMOVE THIS PRODUCT LABLE.
nexAir
Distributed by nexAir, LLC www.nexAir.com
1350 Concourse Ave., Suite 103 Memphis, TN 38104
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-710 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 999 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12213-710-60 113 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 2 NDC:12213-710-13 408 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 3 NDC:12213-710-40 425 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 4 NDC:12213-710-58 586 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 5 NDC:12213-710-50 2067 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 6 NDC:12213-710-12 6145 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 7 NDC:12213-710-20 6201 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 8 NDC:12213-710-21 8240 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 9 NDC:12213-710-22 1019 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205851 06/01/1996 Labeler - NexAir, LLC (927024422) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 010263301 manufacture(12213-710) Establishment Name Address ID/FEI Business Operations NexAir, LLC 927024422 manufacture(12213-710)