Label: HELIUM/OXYGEN MIX gas
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NDC Code(s):
12213-801-01,
12213-801-02,
12213-801-03,
12213-801-04, view more12213-801-05, 12213-801-06, 12213-801-12, 12213-801-13, 12213-801-28
- 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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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S. (OXYGEN, HELIUM)
UN1956
20% OXYGEN USP
80% HELIUM USP
MIXTURE
CAS: (7782-44-7) (7440-59-7)
RX Only
WARNING: Administration of this gas mixture 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 gas mixtures, 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.
Do not handle until all safety precautions have been read and understood. Avoid breathing gas. Use and store only outdoors or in 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 ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
NET CONTENTS
Cylinder Size Cubic Feet Liters (Gaseous)
K 200.4 5675
E 22.0 625
D-puritan 13.5 382
DO NOT REMOVE THIS PRODICT LABEL.
Distributed by nexAir
nexAir, LLC www.nexAir.com
1350 Concourse Ave., Suite 103 Memphis, TN 38104
888-639-2474
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, OXIDIZING, N.O.S. (HELIUM, OXYGEN)
UN3156
% OXYGEN USP
% HELIUM USP MIXTURE CAS: (7782-44-7) (7440-59-7)
RX Only.
WARNING: Administration of this gas mixture 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 gas mixtures, 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.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for oxygen service. Open valve slowly. In case of fire: stop leak if safe to do so. 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.
DO NOT REMOVE THIS PRODICT LABEL.
Net Contents
Cubic Feet Liters
Distributed by nexAir
nexAir, LLC www.nexAir.com
1350 Concourse Ave., Suite 103 Memphis, TN 38104
888-639-2474
-
INGREDIENTS AND APPEARANCE
HELIUM/OXYGEN MIX
helium/oxygen mix gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-801 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 200 mL in 1 L Inactive Ingredients Ingredient Name Strength HELIUM (UNII: 206GF3GB41) 800 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12213-801-13 382 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 2 NDC:12213-801-28 561 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 01/25/2022 3 NDC:12213-801-12 5663 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 4 NDC:12213-801-01 5987.5 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 5 NDC:12213-801-02 5774 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 6 NDC:12213-801-03 6201 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 7 NDC:12213-801-04 586 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 8 NDC:12213-801-05 5856 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 9 NDC:12213-801-06 5938 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 NDA205849 06/01/1996 Labeler - NEXAIR, LLC (927024422) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 010263301 manufacture(12213-801) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 927024422 manufacture(12213-801)