Nitrous Oxide Sedara

Manufacturer
Linde Gas & Equipment Inc.
Effective date
2021-12-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:20:54

Label at a glance#

ProductNitrous Oxide Sedara
Active ingredientNitrous Oxide
Label structure2 sections

Label contents#

Full prescribing information#

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
Sedara Label LPH040E

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25373-703-012025-12-18C16284748780-1f386c64a-3694-0266-e053-dadaa90a7c1a1c6968cf-337e-058b-e8b3-610b26167045
25373-703-012023-01-30C16284748780-1f386c64a-3694-0266-e053-dadaa90a7c1a1c6968cf-337e-058b-e8b3-610b26167045

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25373-703NITROUS OXIDE SEDARA (NITROUS OXIDE) GAS [LINDE GAS & EQUIPMENT INC.]5Legacy NDC20211225_1c6968cf-337e-058b-e8b3-610b26167045.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU10291
Nitrous OxideACTIVE MOIETYK50XQU10291

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25373-70325373-703-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Nitrous OxideK50XQU1029ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
79e98fbd-1c1f-44e0-9397-cd5a86ecd43c1c6968cf-337e-058b-e8b3-610b261670452025-12-18Exact identifier
spl set id: 1c6968cf-337e-058b-e8b3-610b26167045

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.