MedPath

Nitrous Oxide

NITROUS OXIDE, REFRIGERATED LIQUID

Approved
Approval ID

77737bbb-80d5-2858-011d-08b028af6f27

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 14, 2021

Manufacturers
FDA

Linde Gas & Equipment Inc.

DUNS: 805568339

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nitrous Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25373-103
Product Classification
G
Generic Name
Nitrous Oxide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 14, 2018
FDA Product Classification

INGREDIENTS (1)

Nitrous OxideActive
Quantity: 99 L in 100 L
Code: K50XQU1029
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/9/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WARNINGS SECTION

LOINC: 34071-1Updated: 11/14/2018

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


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Nitrous Oxide - FDA Drug Approval Details