Label: NITROUS OXIDE- nitrous oxide gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-103-05, 25373-103-06, 25373-103-07, 25373-103-08 - 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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WARNINGS SECTION
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 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 TYPE LITERS 160L [_] 88737 180L [_] 96871 200L [_] 105006 230L [_] 123492 ____ ____ ____ Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427
LG041G 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:25373-103 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:25373-103-05 88737 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 2 NDC:25373-103-06 96871 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 3 NDC:25373-103-07 105006 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 4 NDC:25373-103-08 123492 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 06/16/1986 Labeler - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 010263301 manufacture(25373-103) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 142591424 manufacture(25373-103) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 069232473 manufacture(25373-103) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833132561 manufacture(25373-103) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016271697 manufacture(25373-103)
