Ketorolac Tromethamine Injection, USP

Sagent Pharmaceuticals

Revision date : 2025-07-26

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

64-17-5

Name of the chemical

Ethanol

Concentration

N/A

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

80-85

General Information

Version

6.0

Revision date

2025-07-26

Product name

Ketorolac Tromethamine Injection, USP

Chemical name

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

1.2.1 Relevant identified uses

Pharmaceutical

Icons in SDS

M004 M009 M010 M017 GHS08

Company Information

company name

Sagent Pharmaceuticals

GHS Information

Signal word

DANGER

Hazard Codes

Hazard statements (CLP)

H360D

Hazard statements

Code

Statements

H360D

May damage the unborn child

Section 2

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

N/A

Signal word

DANGER Hazard statement(s), May damage the unborn child. Symbol(s), and/or May cause damage to gastrointestinal system through

Precautionary statements

prolonged or repeated exposure. (c) Description of Hazards Short Term: Accidental ingestion may cause effects similar to those seen in clinical use. Individuals sensitive to this chemical or other materials in its chemical class may develop allergic reactions. Known Clinical Effects: Other nonsteroidal anti- inflammatory drugs (NSAIDs) are known to impact delivery, late fetal development, and lactation. Ingestion of this material may cause effects similar to those seen in clinical use including serious gastrointestinal toxicity such as bleeding, ulceration, and perforation and kidney toxicity. Clinical use of this drug has caused headache, dizziness, blurred vision, ringing of the ears, skin rash, itching, swelling, liver effects. (d) Unknown Acute Toxicity: N/A

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