300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Ketorolac Tromethamine Injection 15mg/mL; (1mL)
Chemical Names: ?5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with
2-amino-2-(hydroxymethyl)-1,3-propanediol(1:1)
Synonyms: Tora-Dol; Taradyl; Zodol; Taratex; Toratex; Taradol; Lixidol; Toradek; Tarasyn
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (440)232-3320 or (800)562-4797
Medical Emergency: Professional Services: 1(800)521-5169
Date Prepared: April 12, 1999
Date Revised: December 18, 2001
Date Revised: August 26, 2002 (correct type error)
Date Revised: May 18, 2005
Date Revised: July 16, 2007
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component approx. % CAS# OSHA PEL ACGIH TLV Recommended
0.025 mg/m3
Ketorolac Tromethamine 1.5% 74103-07-4 NONE NONE
Ethanol 10.0% 64-17-5 1000 ppm 1000 ppm NONE
Sodium Chloride 0.7% 7647-14-5 NONE NONE NONE
Water for Injection 87.8% 7732-18-5 NONE NONE NONE
Ketorolac is a sterile injectable organic liquid drug provided in a vial.
Sodium Hydroxide and/or Hydrochloric Acid, if necessary for pH adjustment.
Section III - HEALTH HAZARD DATA
Routes of Entry: Product may be absorbed via inhalation or skin or eye absorption.
Health Hazard (Acute & Chronic): Ketorolac is an anti-inflammatory drug used in the treatment of
moderately severe or acute pain. It affects the central nervous system and has relatively low
acute toxicity. Chronic toxicity will result only on excessive repetitive exposure. Chronic
Toxicity effects may be seen at the digestive system.
Carcinogenicity: NTP? NO IARC Monographs? NONE
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OSHA Regulated? NO
Signs & Symptoms of Exposure: Excessive exposure may cause nausea, vomiting, diarrhea, drowsiness,
insomnia, headache, and dizziness.
Medical Conditions Generally Aggravated by Exposure: Allergies to non-steroidal anti-inflammatory
drugs such as aspirin.
BVL Hazard Category: 2
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 minutes.
Skin Exposure: Wash skin with cool, soapy water.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
Inhalation: If difficulty breathing, administer oxygen. Seek attention of a physician immediately.
If necessary, provide artificial respiration.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): Estimated <140癋
Flammable Limits: LEL: 3.3% UEL: 19% based on Ethanol
Extinguishing Media: Use water or a multi-purpose ABC fire extinguisher.
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters should
wear self-contained breathing apparatus to avoid inhalation of smoke.
Unusual Fire/Explosion Hazards: None
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Ketorolac with absorbent materials and dispose according to local,
state, and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating the area; clean up spill immediately to
prevent evaporation.
Release to Water: Refer to local water authority or refer to local, state, and federal disposal guidelines.
Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section VI above. Wear latex or nitrile
gloves and safety glasses when cleaning spills. A dust/mist respirator (N95) with organic vapor
cartridges may be necessary if excess volatiles are generated.
Waste Disposal Method: Dispose of according to local, state, and federal guidelines. Incineration is
recommended.
Precautions to be taken in handling and storing: Refer to local, state, and federal rules.
Other Precautions: Product contains alcohol and should be handled as a flammable liquid
Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
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Respiratory Protection: Under normal use, respirators are not required. If aerosols are generated,
a disposable dust/mist respirator (N95) with organic vapor cartridges may be used. Personnel
wearing respirators should be fit tested and approved for respirator use under the OSHA Respiratory
Protection Standard 29 CFR 1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Latex or nitrile
Eye Protection: Safety glasses or goggles
Other Protective Clothing or Equipment: Lab coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking while handling
this product.
Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approximate to water 1.0
Appearance and Odor: Colorless to slightly yellow Melting Point: NA
liquid with no odor Evaporation Rate: Approximate to water
Boiling Point: Similar to water Solubility in Water: NA
Vapor Pressure: Approximate to water pH: 6.9 to 7.9
Vapor Density: Approximate to water
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): Strong oxidizers and water-reactive materials
Hazardous Decomposition or Byproducts: Decomposition products of this product may include
carbon monoxide, carbon dioxide, and sulfur oxides.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Storage with water-reactive materials
Section XI - TOXICOLOGICAL INFORMATION
For Ketorolac Tromethamine: RTECS # UY7759900
LD50 oral, rat = 189 mg/kg
LD50 oral, mouse = 293 mg/kg
LD50 intraperitoneal, mouse = 225 mg/kg
Additional reproductive health and toxicity data is available from the National Institute for Occupational
Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Ketorolac. Handle in a manner that
prevents spills or releases to the environment.
Section XIII - DISPOSAL INFORMATION
Dispose of by incineration at an approved/permitted incinerator as a characteristic hazardous waste Code
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D001. Review local, state, and federal regulations for your regulatory area.
Section XIV - TRANSPORTATION INFORMATION
Proper Shipping Name: Medicines, flammable liquid, n.o.s., (Ketorolac Solution)
Hazard Class: 3 (flammable liquid)
UN ID Number: NA1993
Packing Group: III
DOT Label(s) Required: Flammable liquid
Emergency Response Guide Number: 27
Ketorolac is not classified as D.O.T. Marine Pollutants
(49 CFR 171.101, Appendix B).
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: Characteristic D001 for flammability
Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address the therapeutic use of this material
2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
Management.
3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2= Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic
4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the
recommended limit of employee exposure to airborne dusts or aerosols that should not be exceeded
over an eight-hour time-weighted average.
This document is generated to distribute health, safety and environmental data. It is not a specification
sheet and none of the displayed data should be construed as a specification. Information on this MSDS
sheet was obtained from sources which we believe are reliable, and we believe that the information is
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complete and accurate. However, the information is provided without any warranty, express or implied,
regarding its correctness. Some of the information presented and conclusions drawn are from sources other
than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of
the product are beyond our control and may also be beyond our knowledge. It is the user's responsibility to
determine the suitability of any material for a specific purpose and to adopt such safety precautions as may
be necessary. If the product is used as a component in another product, this MSDS information may not be
applicable. For these reasons, we do not assume any responsibility and expressly disclaim liability for any
loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal
of this product
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