NITROUS OXIDE SEDARA - nitrous oxide gas 
Linde Gas & Equipment Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

OTHER SAFETY INFORMATION

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.  

RX ONLY
                                 
LPH040E
U.S. patent pending 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

THE LINDE GROUP 
LINDE 
Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd.
Suite 7000
Bridgewater, NJ 08807
866.543.3427

MEDICAL GAS 
For Use With SEDARA® Gas Mixer

NITROUS OXIDE                               
USP
UN 1070
CAS 10024-97-2
Content: 115 liters 
Do Not Remove this Label 

Batch Code
NON-FLAMMABLE GAS 2
OXIDIZER 5.1
!
Use in accordance with the Safety Data Sheet for this product. 

Sedara Label LPH040E
NITROUS OXIDE SEDARA  
nitrous oxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25373-703
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nitrous Oxide (UNII: K50XQU1029) (Nitrous Oxide - UNII:K50XQU1029) Nitrous Oxide990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25373-703-01115 L in 1 CYLINDER; Type 0: Not a Combination Product06/18/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas06/18/2012
Labeler - Linde Gas & Equipment Inc. (805568339)
Registrant - Linde Gas & Equipment Inc. (805568339)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.833132561manufacture(25373-703)

Revised: 12/2021
Document Id: 4f20be6a-a417-406d-ab50-1a462ba6078d
Set id: 1c6968cf-337e-058b-e8b3-610b26167045
Version: 5
Effective Time: 20211214
 
Linde Gas & Equipment Inc.