Note: Ingredients listed on restricted chemical lists
EC/CAS
7727-37-9
Name of the chemical
Nitrogen N2
Concentration
>99
General Information
Version
05
Revision date
2018-12-14
Product name
INOmax
Product Synonyms
INOmax® (800 ppm) * Nitric Oxide (0.08%) Blended with Nitrogen (99.92%) * INOflo®
1.2.1 Relevant identified uses
Pharmaceutical grade nitric oxide for inhalation balanced in nitrogen. Nitric oxide is a pulmonary vasodilator and the active substance in these products. The gaseous blend of nitric oxide and nitrogen gas is supplied in aluminum cylinders as a compress...
Manufacturer Name
Mallinckrodt Manufacturing LLC
Emergency telephone
1-800-424-9300, +1-703-741-5970
Icons in SDS
Company Information
company name
Mallinckrodt Manufacturing LLC
e-mail address of the competent person responsible for the Safety Data Sheet
Brands.SDS@mnk.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H280
Hazard statements
Code
Statements
H280
Contains gas under pressure; may explode if heated
Section 2
SECTION 2: Hazards identification
Physical hazards
Gases under pressure Compressed gas
Health hazards
Not classified
Environmental hazards
Not classified
Contains
NITRIC OXIDE, NITROGEN
Signal word
Warning
Hazard statements
Contains gas under pressure; may explode if heated. May displace oxygen and cause rapid suffocation.
Prevention
Keep container tightly closed. Use only outdoors or in a well-ventilated area. Wear respiratory protection.
Response
Get medical advice/attention if you feel unwell.
Storage
Protect from sunlight. Store in a well-ventilated place.
Disposal
Dispose of contents/container in accordance with local/regional/national/international regulations. Hazard(s) not otherwise Exposure to rapidly expanding gas or vaporizing liquid may cause frostbite ("cold burn"). classified (HNOC) Exposure may aggravate those with pre-existing eye, skin, or respiratory conditions. Those with pre-existing heart, lung, or blood disorders may be more susceptible to the symptoms of asphyxia Nitric oxide converts to nitrogen dioxide when exposed to air Federal law prohibits dispensing without a prescription. Used in the treatment of prescribed medical disorders. Administration of this gas mixture may be hazardous or contraindicated. Use only under the supervision of an experienced licensed practitioner familiar with the indications for use, dosages, methods, hazards, contraindications, and side effects
Additional information
The hazard warnings associated with this product are based on the individual ingredients included in the finished dosage form of the pharmaceutical product. The supplied package insert (approved labeling) provides the necessary drug safety information. As per 29 CFR 1910.1200(b)(5)(iii), any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and regulations issued under that Act, when they are subject to the labeling requirements under that Act by the Food and Drug Administration are exempted from the requirements of the Hazard Communication Standard. All Mallinckrodt finished products are labeled in compliance with the requirements of the Food and Drug Administration (FDA) and must be used in the prescribed manner. Each package of the finished pharmaceutical product is supplied with a package insert (approved labeling) which provides necessary drug safety information.
2.1 Classification of the substance or mixture
Not classified. Environmental hazards Not classified. OSHA defined hazards Simple asphyxiant