Ketorolac Tromethamine Injection, USP

Alvogen, Inc

Revision date : 2017-07-18

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GHS02 GHS07
Health risk rating 2
Safety risk rating 3
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

87.8%

EC/CAS

200-578-6/64-17-5

Name of the chemical

Ethanol

Concentration

10.0%

General Information

Revision date

2017-07-18

Product name

Ketorolac Tromethamine Injection, USP

Product Synonyms

±-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxyli acid, Compound with 2- amino-2-(hydroxymethyl)-1,3- propanediol (1:1)

1.2.1 Relevant identified uses

Pharmaceutical, Injectable

Manufacturer Name

Alvogen, Inc

Emergency telephone

1-844-842-8672

Icons in SDS

GHS02 GHS07

Company Information

company name

Alvogen, Inc

GHS Information

Signal word

Danger!

Hazard Codes

Hazard statements (CLP)

H225, H315

Hazard statements

Code

Statements

H225

Highly Flammable liquid and vapour

Section 2

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW

Product definition

This product is a clear, colorless to slightly yellow liquid with no odor

Health hazards

Common adverse effects to excessive exposure include nausea, vomiting, gastrointestinal irritation, diarrhea, fatigue, insomnia, headache and dizziness. Flammability Hazards: This product is combustible with a flash point of 106⁰F. 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

Signal word

Danger!

Classification according to GHS

Flammable Liquid Category 2 Skin Irritant Category 2 Eye Irritant Category 2

Precautionary statements

H225 Flammable liquid and vapor P210: Keep away from flames and hot surfaces. No H315: Causes skin irritation Smoking P264: Wash skin after handling. 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 injection, ingestion, inhalation and skin or eye contact. ACUTE: Common adverse effects to excessive exposure include nausea, vomiting, gastrointestinal irritation, diarrhea, fatigue, insomnia, headache and dizziness. CHRONIC: Chronic toxicity will result only on excessive repetitive exposure. Chronic Toxicity effects may be seen at the digestive system. TARGET ORGANS Acute Skin, Eyes, Digestive System Chronic: Digestive System

2.1 Classification of the substance or mixture

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: EC# 231-791-2 This substance is not classified in the Annex VI EC# 200-578-6 This substance is classified in the Annex VI, Index# 603-002-00-5 EC# 620-545-3 This substance is not classified in the Annex VI EC# 231-132-9 This substance is not classified in the Annex VI Substances not listed either individually or in group entries must be self classified. Component(s) Contributing to Classification(s) All Ingredients

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