NITRIC OXIDE NITROGEN MIX gas

Nitric Oxide Nitrogen Mix by

Drug Labeling and Warnings

Nitric Oxide Nitrogen Mix by is a Prescription medication manufactured, distributed, or labeled by Airgas Specialty Gases. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

CareFusion
ViaNOx-H 5000ppm   Nitric Oxide 5000ppm (0.5% v/v)
CAUTION: Contains a New Drug – Limited by Federal Law (USA) to Investigational Use Only
Compressed Gases, N.O.S. (Nitric Oxide, Nitrogen)    UN1956
Topical, Rx Only NOT FOR INHALATION BEYOND THE NASOPHARYNX
Label No:  NDC  67200-004-01
Airgas Product Code: XO2NI99EA22C498
CareFusion Code: 79072
Cylinder Contents: 550 liters @ 70F     5000ppm (0.5% v/v) Nitric Oxide Balanced in Nitrogen USP/NF Please see Certificate of Analysis for assay result if exact value is needed
CAS Numbers: 10102-43-9 NO      7727-37-9   N2
Read and understand Material Safety Data Sheet before use. Indications and Directions: Use only in accordance with Institutional Review Board approved protocol.
WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, testing methods, and with the hazards, contraindications, and side effects and precautions to be taken.
CAUTION: High pressure gas. Can cause rapid suffocation without warning. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. Cylinder temperature should not exceed 125F (52C).
FIRST AID: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.
Return with 150 psig. To be refilled only by a pharmaceutical facility authorized by CareFusion.
Manufactured for: CareFusion 207, Inc. 22745 Savi Ranch Parkway Yorba Linda, CA 92887-4668 USA For product inquiry: 1-314-283-1830
Manufactured by: Airgas Specialty Gases 12722 South Wentworth Avenue Chicago, IL 60628
Do Not Remove This Label.                                     80889-04  (01/10)

INGREDIENTS AND APPEARANCE

NITRIC OXIDE NITROGEN MIX 
nitric oxide nitrogen mix gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67989-011
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nitric Oxide (UNII: 31C4KY9ESH) (Nitric Oxide - UNII:31C4KY9ESH)	Nitric Oxide	5 mL  in 1 L
Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75)	Nitrogen	955 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67989-011-01	550 L in 1 CYLINDER
2	NDC: 67989-011-02	209.6 L in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		05/01/2010

Labeler - Airgas Specialty Gases (097167860)

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Specialty Gases		097167860	manufacture