FDA Label for Nitric Oxide Nitrogen Mix
View Indications, Usage & Precautions
Nitric Oxide Nitrogen Mix Product Label
The following document was submitted to the FDA by the labeler of this product Airgas Specialty Gases. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.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)
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