INOmax

Mallinckrodt Manufacturing LLC

Revision date : 2018-12-14

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GHS04
Health risk rating 2
Safety risk rating 4
Environmental risk rating 1

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

GHS04 M004 M009 M010 M011 M017 T019

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

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