NITROUS OXIDE SEDARA- nitrous oxide gas

Nitrous Oxide Sedara by

Drug Labeling and Warnings

Nitrous Oxide Sedara by is a Prescription medication manufactured, distributed, or labeled by Linde Gas North America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. 

INGREDIENTS AND APPEARANCE

NITROUS OXIDE SEDARA  
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 25373-703
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: 25373-703-01	115 L in 1 CYLINDER; Type 0: Not a Combination Product	06/18/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		06/18/2012

Labeler - Linde Gas North America LLC (805568339)

Registrant - Linde Gas North America LLC (805568339)

Establishment
Name	Address	ID/FEI	Business Operations
Linde Gas North America LLC		833132561	manufacture(25373-703)