NITROUS OXIDE SEDARA

Main information

  • Trade name:
  • NITROUS OXIDE SEDARA - nitrous oxide gas
  • Composition:
  • Nitrous Oxide 990 mL in 1 L
  • Administration route:
  • RESPIRATORY (INHALATION)
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NITROUS OXIDE SEDARA - nitrous oxide gas
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • unapproved medical gas
  • Authorization number:
  • 25373-703-01
  • Last update:
  • 27-05-2019

Summary of Product characteristics: dosage, interactions, side effects

NITROUS OXIDE SEDARA - nitrous oxide gas

Linde Gas North America LLC

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.

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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

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.

NITROUS OXIDE SEDARA

nitrous oxide gas

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:25373-70 3

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nitro us O xide (UNII: K50 XQU10 29 ) (Nitro us Oxide - UNII:K50 XQU10 29 )

Nitro us Oxide

9 9 0 mL in 1 L

Linde Gas North America LLC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:25373-70 3-0 1

115 L in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct

0 6 /18 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved medical gas

0 6 /18 /20 12

Labeler -

Linde Gas North America LLC (805568339)

Registrant -

Linde Gas North America LLC (805568339)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Linde Gas No rth America LLC

8 3313256 1

ma nufa c ture (25373-70 3)

Revised: 10/2017