Label: NITROUS OXIDE gas
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NDC Code(s):
12213-593-11,
12213-593-12,
12213-593-13,
12213-593-14, view more12213-593-15, 12213-593-16, 12213-593-17, 12213-593-18, 12213-593-19, 12213-593-20, 12213-593-21, 12213-593-22, 12213-593-23, 12213-593-24, 12213-593-25, 12213-593-28, 12213-593-37, 12213-593-58
- Packager: NEXAIR, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 11, 2024
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PRINCIPAL DISPLAY PANEL
REFRIGERATED LIQUID
NITROUS OXIDE, REFRIGERATED LIQUID, USP
UN2201
CAS: 10024-97-2
LOT #
NET CONTENTS
Part # C.F Liters
LQ NO-USP-L1 3519 99,654
RX Only
WARNING: Administration of Nitrous Oxide 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 Nitrous Oxide 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 REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION.
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. Avoid breathing gas. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.
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
NITROUS OXIDE USP
UN1070
DO NOT REMOVE THIS LABEL
RX only. WARNING: Administration of Nitrous Oxide 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 Nitrous Oxide 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 CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. 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. Avoid breathing gas. Do not get in eyes, on skin, or on clothing. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. 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. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. WARNING: This product contains a chemical know to the state of California to cause birth defects or other reproductive harm. CAS: 10024-97-2
Distributed by nexAir
nexAir, LLC www.nexAir.com
1350 Concourse Ave., Suite 103 Memphis, TN 38104
888-639-2474
LOT #:
PART #:
C.F. LITERS:
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-593 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12213-593-13 986 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 2 NDC:12213-593-58 1577 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 3 NDC:12213-593-11 4928 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 01/25/2022 4 NDC:12213-593-37 7885 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 5 NDC:12213-593-12 13798 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 01/25/2022 6 NDC:12213-593-28 99647 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 7 NDC:12213-593-14 1628 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 8 NDC:12213-593-15 2468 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 9 NDC:12213-593-16 14328 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 10 NDC:12213-593-17 13818 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 11 NDC:12213-593-18 4936 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 12 NDC:12213-593-19 15818.5 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 13 NDC:12213-593-20 17798 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 14 NDC:12213-593-21 4063 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 15 NDC:12213-593-22 170 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 16 NDC:12213-593-23 408 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996 17 NDC:12213-593-24 180 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/1996 18 NDC:12213-593-25 113 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 NDA206009 06/01/1996 Labeler - NEXAIR, LLC (927024422) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 010263301 manufacture(12213-593) Establishment Name Address ID/FEI Business Operations NEXAIR, LLC 927024422 manufacture(12213-593) Establishment Name Address ID/FEI Business Operations Nexair, LLC 969017086 manufacture(12213-593)