Label: CARBON DIOXIDE/OXYGEN MIX gas
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NDC Code(s):
12213-800-01,
12213-800-02,
12213-800-03,
12213-800-04, view more12213-800-05, 12213-800-06, 12213-800-14, 12213-800-58
- 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
COMPRESSED GASES, OXIDIZING, N.O.S (OXYGEN, CARBON DIOXIDE)
UN3156
RX only
% CARBON DIOXIDE, USP
% OXYGEN, USP
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. MAY INCREASE RESPIRATION AND HEART RATE. MAY CAUSE FROSTBITE. Do not get in eyes, on skin, or on clothing. 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 a well-ventilated place. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. 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.
CAS: OXYGEN 7782-44-7 CARBON DIOXIDE 124-38-9
FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
NET CONTENTS
Contains Cubic Feet at 70 F and PSIG
DO NOT REMOVE THIS PRODUCT LABEL.
Distributed by nexAir
nexAir, LLC www.nexAir.com
1350 Concourse Ave., Suite 103 Memphis, TN 38104
888-639-2474
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INGREDIENTS AND APPEARANCE
CARBON DIOXIDE/OXYGEN MIX
carbon dioxide/oxygen mix gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-800 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 50 mL in 1 L Inactive Ingredients Ingredient Name Strength CARBON DIOXIDE (UNII: 142M471B3J) 950 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12213-800-14 6400 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 01/25/2022 2 NDC:12213-800-58 708 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 01/25/2022 3 NDC:12213-800-01 6405 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 4 NDC:12213-800-02 6374 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 5 NDC:12213-800-03 586 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 6 NDC:12213-800-04 705 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 7 NDC:12213-800-05 645.5 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 8 NDC:12213-800-06 6020 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(12213-800) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 927024422 manufacture(12213-800)