Label: NITROUS OXIDE- nitrous oxide gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-003-01, 25373-003-02, 25373-003-04, 25373-003-05 - Packager: Linde Gas & Equipment Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 14, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Linde
NITROUS OXIDE USP
UN1070
2
5.1
!
MEDICAL GAS
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 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 can expose you to nitrous oxide, which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
DO NOT REMOVE THIS LABEL.
CONTENTS: Cylinder
TypeLiters K 13810 [_] M 7386 [_] E 1726 [_] D 991 [_] _______ _______ _______ Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427
LG040G 8/18
Linde
NITROUS OXIDE USP
UN1070
CAS 10024-97-2
2
5.1
!
MEDICAL GAS
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 effect, 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 black 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 can expose you to nitrous oxide, which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
DO NOT REMOVE THIS PRODUCT LABEL.
CONTENTS: Cylinder
TypeLiters K 13810 [_] M 7386 [_] E 1726 [_] _______ _______ _______ Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427MG016H 8/18
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25373-003 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 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25373-003-01 991 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 2 NDC:25373-003-02 1726 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 3 NDC:25373-003-04 13810 L in 1 CYLINDER; Type 0: Not a Combination Product 11/27/1990 4 NDC:25373-003-05 7386 L in 1 DEWAR; Type 0: Not a Combination Product 11/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 11/27/1990 Labeler - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 010263301 manufacture(25373-003) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 142591424 manufacture(25373-003) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833132561 manufacture(25373-003) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016271697 manufacture(25373-003)