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
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