300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Haloperidol Lactate 5mg/mL (1mL/vial and 10mL/vial)
Chemical Names: 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4-fluorobutyrophenone)
Synonyms: Haldol? Aldoperiden, Dozic, Einalon S, Galoperidol, Fortunan, Linton, Pernox, Serenace
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: (800) 424-9300
Telephone Number for Info.: (440) 232-3320 or (800) 562-4797
Medical Emergency: Professional Services: (800) 521-5169
Date Prepared: March 14, 2001
Date Revised: December 18, 2001
Date Revised: July 16, 2007
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
Haloperidol USP 0.5 52-86-8 NONE NONE NONE
Methylparaben 0.18 99-76-3 NONE NONE NONE
Propylparaben 0.02 94-13-3 NONE NONE NONE
Lactic Acid/adjust pH 0.38 50-21-5 NONE NONE NONE
Water for Injection 98.92 7732-18-5 NONE NONE NONE
Haloperidol Lactate is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Product may be absorbed via inhalation, ingestion, or skin contact.
Health Hazard (Acute & Chronic): Haloperidol is a drug used in the treatment of psychotic disorders.
Irritation of eyes, skin, and respiratory system may result. Product affects the central nervous,
cardiovascular and digestive systems. Allergic reactions may occur. Haloperidol
is teratogenic and may have adverse affects on a developing fetus. Chronic exposures may cause
mammary tumors or breast cancer.
Carcinogenicity: NTP? NO IARC Monographs? NONE
OSHA Regulated? NO
Signs & Symptoms of Exposure: Excessive exposure may cause restlessness, blurred vision, constipation,
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dry mouth, muscle twitching and spasms, weakness/stiffness in arms or legs, secretion of breast
milk, breathing difficulty, rapid heart rate and muscle spasms. Irritation may also occur.
Medical Conditions Generally Aggravated by Exposure: Active alcoholism, severe cardiovascular
disease, epilepsy, glaucoma, impaired liver or kidney function, hyperthyroidism, thryotoxosis,
Parkinsons disease, asthma, and other respiratory illnesses.
BVL Hazard Category: 3
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes.
Skin Exposure: Wash skin with cool, soapy water.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately. If person is
conscious, induce vomiting. Never induce vomiting on an unconscious person.
Inhalation: If difficulty breathing, administer oxygen. Seek attention of a physician immediately.
*If necessary, counteract hypotension and circulatory collapse by use of intravenous fluids, plasma,
or concentrated albumin and vasopressor agents such as norepinephrine. Administer benztropine or
diphenhydramine to manage severe extrapyramidal reactions. Epinephrine should not be used.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): >200癋 Cleveland Closed Cup LEL: not available UEL: not available
Flammable Limits: Not Available
Extinguishing Media: Use a multi-purpose ABC extinguisher.
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters must
wear self-contained breathing apparatus to avoid inhalation of smoke.
Unusual Fire/Explosion Hazards: None
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Prevent entry of Haloperidol Lactate into waterways. Use absorbents to wipe up spills.
Soap and water may be used to decontaminate surfaces.
Release to Air: If aerosols are generated, reduce exposures by ventilating area and wear respiratory
protection.
Release to Water: Refer to local water authority; drain disposal is not recommended. Refer to local, state
and federal 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 all necessary
protective equipment including nitrile gloves, protective clothing, safety glasses and an air-purifying
respirator with HEPA (P100) and organic vapor cartridges.
Waste Disposal Method: Dispose of waste according to local, state, and federal guidelines. Incineration is
recommended.
Precautions to be taken in handling and storing: Store product at 15-30癈 or 59-86癋. Protect from light
Do not freeze.
Other Precautions: None
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,
an air-purifying respirator with HEPA (P100) and organic vapor cartridges may be worn. For large
spill emergencies, SCBA may be required. Personnel wearing respirators should be fit
tested and approved for respirator use under the OSHA Respiratory Protection Standard 29 CFR
1910.134.
Ventilation: Use with adequate ventilation.
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
Appearance and Odor: Pale yellow, clear with odor Melting Point: Liquid at room temperature
Boiling Point: Approximate to water Evaporation Rate: Approximate to water
Vapor Pressure: Approximate to water Solubility in Water: Soluble
Vapor Density: Approximate to water pH: 3.0-3.6
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): Oxidizers
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts of nitrogen oxides, carbon monoxide, and sulfur dioxide.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Avoid contact with oxidizers
Section XI - TOXICOLOGICAL INFORMATION
Toxicity data is for the active ingredient, Haloperidol: RTECS # EU1575000
LD50 oral, rat = 128 mg/kg LD50 intravenous, mouse = 13 mg/kg
LD50 oral, mouse = 71 mg/kg LD50 oral, dog = 90 mg/kg
LD50 intraperitoneal, rat = 27 mg/kg TDLo multiple man = 343 ug/kg
LD50 intraperitoneal, mouse = 30 mg/kg LD50 intravenous, dog = 18 mg/kg
LD50 subcutaneous, mouse = 41 mg/kg
Additional reproductive health 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 Haloperidol. Handle in a manner to
prevent spills or releases to the environment.
Section XIII - DISPOSAL INFORMATION
Dispose of according to local, state, and federal guidelines. Recommend disposal via incineration
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in an approved, licensed incinerator.
Section XIV - TRANSPORTATION INFORMATION
Haloperidol Lactate is not D.O.T. hazardous according to 49 CFR 172.101
Haloperidol Lactate not a Marine Pollutant
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
Listed on California's Proposition 65 as Code DF
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.
5. Haloperidol Lactate may be considered a Hazardous Drug as described in the NIOSH Alert:
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care
Settings. Employees who prepare or administer hazardous drugs or who work in areas where these
drugs are used should follow specific handling guidelines in order to prevent exposure to these
agents in the air or on work surfaces, clothing, or equipment.
6. The Following Guidance Information is excerpted from the NIOSH Alert:
Elements of a Hazardous Drug Handling Program include:
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? Establishment and implementation of written policies and protocols to ensure the safe
handling of oncolytic and/or potent drugs, including receipt of product.
? Training and education of employees on the recognition, evaluation and control of
Hazardous Drugs
? Effective Planning and design of the workplace
? Use of best practice control measures and specialized equipment such as ventilated cabinets
or isolators designed for worker protection
? Wearing recommended personal protective equipment
? An integrated health surveillance program that: includes the assessment and counseling of
prospective employees before they commence any work involving oncolytic and/or potent
drugs and related waste
7. Published guidance on the handling and transport of cytotoxic drugs:
NIOSH Alert ?Preventing occupational exposures to antineoplastic and other hazardous drugs in
health care settings
http://www.cdc.gov/niosh/docs/2004-165/
National Study Commission on Cytotoxic Exposure: Recommendation for handling Cytotoxic
Agents:
http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm
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 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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