Nitroglycerin Transdermal Delivery System

Alvogen, Inc

Revision date : 2015-06-02

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-240-8/55-63-0

Name of the chemical

Nitroglycerin; Propane-1,2,3-triyl trinitrate

Concentration

75% 25%

General Information

Revision date

2015-06-02

Product name

Nitroglycerin Transdermal Delivery System

Product Synonyms

None known

Manufacturer Name

Alvogen, Inc

Emergency telephone

1-844-842-8672

Icons in SDS

GHS08

Company Information

company name

Alvogen, Inc

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H373

Hazard statements

Code

Statements

H373

May cause damage to organs through prolonged or repeated exposure

Section 2

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW:

Product definition

This product is a transdermal patch (Solid) carrying nitroglycerin with no odor

Health hazards

Exposure to this product is not expected to cause irritation to eyes. Ingredients may be absorbed through skin and cause target organ effects. Acute nitroglycerin overexposure may cause hypotension, nausea, vomiting, abdominal cramps, headache, mental confusion, delirium, slowed breathing and heart rate, paralysis, convulsions, methemoglobinemia, cyanosis, circulatory collapse and death. Flammability Hazards: This product is non-flammable. Reactivity Hazards: None known

Environmental hazards

The Environmental effects of this product have not been investigated. Release of this product is not expected to have significant adverse effects in the aquatic environment. US DOT SYMBOLS CANADA (WHMIS) SYMBOLS EUROPEAN and (GHS) Hazard Symbols Non-Regulated Material

Signal word

2.1 CLASSIFICATION OF SUBSTANCE OR MIXTURE IN ACCORDANCE WITH 29 CFR 1200 (OSHA HCS) AND THE EUROPEAN UNION DIRECTIVES: This product does meet the definition of a hazardous substance or preparation as defined by 29 CFR 1910. 1200 AND the European Union Council Directives 67/548/EEC, 1999/45/EC, 1272/2008/EC and subsequent Directives. EU HAZARD CLASSIFICATION OF INGREDIENTS PER DIRECTIVE 1272/2008/EC: Index Number: Acrylic Copolymer is not listed in ESIS CAS# 9002-88-4 is not listed in ESIS EC# 200-240-8 Annex VI Index# 603-034-00-X EC# 203-889-5 This substance is classified in the Annex VI of Directive 67/548/EEC. Index# 607-023-00-0 EC# 248-337-4 This substance is not classified in the Annex VI of Directive 67/548/EEC Substances not listed either individually or in group entries must be self classified. Component(s) Contributing to Classification(s) Nitroglycerin

Classification according to GHS

STOT RE Category 2

Precautionary statements

H373: Causes damage to organs through prolonged or P264: Wash skin after handling. repeated exposure 2.3 HEALTH HAZARDS OR RISKS FROM EXPOSURE: SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The most significant routes of exposure for this product are by skin contact or skin absorption. ACUTE: INHALATION: No health effects are expected due to physical properties of the product. CONTACT WITH SKIN: Contact with the skin during product use may result in mild irritation. May be absorbed through skin and cause target organ damage. EYE CONTACT: Contact not expected due to physical properties of the product. INGESTION: Physical blockage. Ingestion may cause gastrointestinal irritation which may include abdominal pain, nausea, diarrhea, and vomiting. May be absorbed following ingestion and cause target organ effects. CHRONIC: Chronic overexposure may cause severe headaches, hallucinations and skin rash. TARGET ORGANS Acute Skin Chronic: Various Target Organs

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