Nitrous Oxide by Praxair Distribution Southeast LLC NITROUS OXIDE gas

Nitrous Oxide by

Drug Labeling and Warnings

Nitrous Oxide by is a Prescription medication manufactured, distributed, or labeled by Praxair Distribution Southeast LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

UN2201 NITROUS OXIDE, REFRIGERATED LIQUID, USP DANGER! COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION. CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE DIZZINESS AND DROWSINESS. MAY CAUSE NERVOUS SYSTEM AND BLOOD CELL DAMAGE. REPRODUCTIVE HAZARD. MAY CAUSE FROSTBITE. TLV-TWA: 50 PPM (ACGIH 2008). ODOR: SLIGHTLY SWEET. Avoid breathing gas. Store and use with adequate ventilation. Keep oil, grease, and combustibles away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Do not get liquid in eyes, on skin, or on clothing. Cylinder temperature should not exceed 125°F (52°C). For liquid withdrawal wear face shield and gloves. Do not drop. Use suitable hand truck for container movement. Avoid spills. Do not walk on or roll equipment over spills. Close valves after each use; keep closed even when empty. Always secure cylinder. Use a backflow prevention device in any piping. Use per Praxair MSDS form P-6226, Praxair safety booklet P-14-153, and manufacturer's operating instructions for this container. Obtain Praxair publications from your local supplier. Rx ONLY FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, qualified personnel may give oxygen. Call a physician. IN CASE OF FROSTBITE, obtain medical treatment immediately. 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. DO NOT REMOVE THIS LABEL Rx ONLY CAS 10024-97-2 PRODUCED BY AIR LIQUEFACTION IN CASE OF EMERGENCY: CALL 1-800-645-4633 DISTRIBUTED BY PRAXAIR, INC., DANBURY PMG-16 (09/08) Copyright @ 2002, 2005, 2008. Praxair Technology, Inc. All rights reserved Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113 DISTRIBUTED BY PRAXAIR, INC., DANBURY

PRINCIPAL DISPLAY PANEL

UN1070 NITROUS OXIDE USP CAS: 10024-97-2 CONTENTS LOT NUMBER WARNING! HIGH-PRESSURE OXIDIZING LIQUID AND GAS.VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION.CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE NERVOUS SYSTEM AND BLOOD CELL DAMAGE. REPRODUCTIVE HAZARD. MAY CAUSE FROSTBITE MAY CAUSE DIZZINESS AND DROWSINESS. TLV-TWA: 50 PPM (ACGIH 2007) ODOR: SLIGHTLY SWEET. Avoid breathing gas. Store and use with adequate ventilation. Keep oil, grease, and combustibles away. Use only use with equipment cleaned as for oxygen service and rated for cylinder pressure. Do not get liquid in eyes, or on skin, or in clothing. Cylinder temperature should not exceed 125’F (52’C). Open valve slowly. Close valve after each use. Keep closed even when empty. Always secure cylinder. Install cap If provided, when not in use. Use backflow prevention device in any piping. Use per Praxair MSDS form P-4636. Praxair safety booklet P-14-153. And manufacturer’s operating instructions for this container. Obtain Praxair publications from your local supplier. Rx ONLY FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, qualified personnel may give oxygen. Call a physician. IN CASE OF FROSTBITE, obtain medical treatment immediately. 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. IN CASE OF EMERGENCY: CALL 1-800-645-4633 DISTRIBUTED BY PRAXAIR, INC., DANBURY DO NOT REMOVE THIS LABEL PMG-4 (11/07) Copyright @ 2002, 2005, 2007, Praxair Technology, inc. Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113 DISTRIBUTED BY PRAXAIR, INC., DANBURY

INGREDIENTS AND APPEARANCE

NITROUS OXIDE 
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49972-004
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: 49972-004-01	17987 L in 1 CYLINDER
2	NDC: 49972-004-02	15770 L in 1 CYLINDER
3	NDC: 49972-004-03	14784 L in 1 CYLINDER
4	NDC: 49972-004-04	9610 L in 1 CYLINDER
5	NDC: 49972-004-05	7885 L in 1 CYLINDER
6	NDC: 49972-004-06	4928 L in 1 CYLINDER
7	NDC: 49972-004-07	2664 L in 1 CYLINDER
8	NDC: 49972-004-08	1725 L in 1 CYLINDER
9	NDC: 49972-004-09	1232 L in 1 CYLINDER
10	NDC: 49972-004-10	986 L in 1 CYLINDER
11	NDC: 49972-004-11	493 L in 1 CYLINDER
12	NDC: 49972-004-12	246 L in 1 CYLINDER
13	NDC: 49972-004-15	46816 L in 1 DEWAR
14	NDC: 49972-004-16	88458 L in 1 DEWAR
15	NDC: 49972-004-17	93632 L in 1 DEWAR
16	NDC: 49972-004-18	107667 L in 1 DEWAR
17	NDC: 49972-004-19	130099 L in 1 DEWAR
18	NDC: 49972-004-20	141680 L in 1 DEWAR
19	NDC: 49972-004-13	17248 L in 1 DEWAR
20	NDC: 49972-004-14	1971 L in 1 DEWAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		10/01/2007

Labeler - Praxair Distribution Southeast LLC (008455552)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution Southeast LLC		969017086	manufacture(49972-004)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution Southeast LLC		192167567	manufacture(49972-004)