Ketorolac

SYNTEX (U.S.A.) INC -- TORADOL IM INJECTABLE -- 6505-01-319-8245
=====================  Product Identification  =====================

Product ID:TORADOL IM INJECTABLE
MSDS Date:10/09/1992
FSC:6505
NIIN:01-319-8245
MSDS Number: BSYPQ
=== Responsible Party ===
Company Name:SYNTEX (U.S.A.) INC
Address:3401 HILLVIEW AVENUE
City:PALO ALTO
State:CA
ZIP:94304
Country:US
Info Phone Num:415-796-5050
Emergency Phone Num:415-796-5050
CAGE:26282
=== Contractor Identification ===
Company Name:SYNTEX (U.S.A.) INC
Address:3401 HILLVIEW AVENUE
Box:City:PALO ALTO
State:CA
ZIP:94304
Country:US
Phone:415-796-5050
CAGE:26282

=============  Composition/Information on Ingredients  =============

Ingred Name:KETOROLAC TROMETHAMINE
CAS:74103-07-4
Fraction by Wt: 1.5 -3%
Other REC Limits:NONE RECOMMENDED

Ingred Name:ETHYL ALCOHOL (ETHANOL) INGREDIENTS 2, 3 & 4 EQUAL 97-98.5%
CAS:64-17-5
RTECS #:KQ6300000
Fraction by Wt: 97-98.5%
Other REC Limits:NONE RECOMMENDED
OSHA PEL:1000 PPM
ACGIH TLV:1000 PPM; 9394

Ingred Name:SODIUM CHLORIDE INGREDIENTS 2, 3 & 4 EQUAL 97-98.5 %
CAS:7647-14-5
RTECS #:VZ4725000
Fraction by Wt: 97-98.5%
Other REC Limits:NONE RECOMMENDED

Ingred Name:WATER INGREDIENTS 2, 3 & 4 EQUAL 97 - 98.5 %
CAS:7732-18-5
RTECS #:ZC0110000
Fraction by Wt: 97-98.5%
Other REC Limits:NONE RECOMMENDED

Ingred Name:SODIUM HYDROXIDE AND/OR HYDROCHLORIC ACID ARE ADDED TO
    ADJUST PH OF PRODUCT.
RTECS #:9999999ZZ
Other REC Limits:NONE RECOMMENDED

=====================  Hazards Identification  =====================

LD50 LC50 Mixture:ORAL LD50 = 200 TO 225 MG/KG (RATS)
Routes of Entry: Inhalation:YES  Skin:YES  Ingestion:YES
Reports of Carcinogenicity:NTP:NO    IARC:YES	 OSHA:NO
Health Hazards Acute and Chronic:MAY IRRITATE EYES. REPEATED ORAL OR
    INTRAMUSCULAR DOSES MAY CAUSE GASTROINTESTINAL COMPLAINTS AND
    CENTRAL NERVOUS SYSTEM EFFECTS. DUE TO LOW CONCENTRATIONS IN
    PRODUCT, THESE ADVERSE EFFECTS WOULD BE E XPECTED ONLY IN CASES OF
    EXTREME MISUSE, E.G., INGESTION OF LARGE QUANTITIES OR REPEATED
    INGESTION.
Explanation of Carcinogenicity:ETHANOL IS LISTED BY IARC AS A
    CARCINOGEN.
Effects of Overexposure:EYE IRRITATION, NAUSEA, VOMITING, DIARRHEA,
    DROWSINESS, INSOMNIA, HEADACHE, DIZZINESS.
Medical Cond Aggravated by Exposure:ALLERGY TO NON-STEROIDAL
    ANTI-INFLAMMATORY DRUGS (E.G. ASPIRIN).

=======================  First Aid Measures  =======================

First Aid:INHALATION: REMOVE FROM EXPOSURE. RESTORE BREATHING. KEEP
    WARM AND QUIET. GET MEDICAL ATTENTION. SKIN: WASH AFFECTED AREA
    THOROUGHLY WITH SOAP AND WATER. IF IRRITATION PERSISTS, GET MEDICAL
    ATTENTION.	EYES: FLUSH WITH LARGE AMOUNTS OF WATER FOR 15 MINUTES.
    GET MEDICAL ATTENTION. INGESTION: DRINK A MODERATE AMOUNT (8-12OZ)
    OF WATER AND NOTIFY MEDICAL PERSONNEL.

=====================  Fire Fighting Measures  =====================

Flash Point:120F,49C
Lower Limits:3.3% ETHANOL
Upper Limits:19% ETHANOL
Extinguishing Media:WATER, MULTIPURPOSE DRY CHEMICAL OR HALON FIRE
    EXTINGUISHER
Fire Fighting Procedures:WEAR FULL PROTECTIVE CLOTHING AND NIOSH/MSHA
    APPROVED POSITIVE PRESSURE, SELF-CONTAINED BREATHING APPARATUS.
    WASH ALL EQUIPMKENT THOROUGHLY AFTER USE.
Unusual Fire/Explosion Hazard:NONE SPECIFIED BY MANUFACTURER.

==================  Accidental Release Measures  ==================

Spill Release Procedures:TAKE PROPER PRECAUTIONS TO MINIMIZE EXPOSURE
    BY USING PROPER PERSONAL PROTECTIVE EQUIPMENT. RETAIN SPILL. SOAK
    UP WITH ABSORBENT MATERIAL, E.G. PAPER TOWELS. WASH SPILL AREA
    THOROUGHLY WITH SOAP AND W ATER. COLLECT FOR DISPOSAL.
Neutralizing Agent:NONE SPECIFIED BY MANUFACTURER.

======================	Handling and Storage  ======================

Handling and Storage Precautions:AVOID EXCESSIVE CONTACT WITH SKIN,
    EYES OR CLOTHING. USE ADEQUATE VENTILATION TO MINIMIZE EXPOSURE.
    WASH THOROUGHLY AFTER HANDLING. STORE IN COOL AREA
Other Precautions:MAY CAUSE GASTROINTESTINAL TOXICITY, EG, ULCERATION,
    BLEEDING, PERFORATION, IF IMPORPERLY HANDLED AND EXCESSIVE EXPOSURE
    OCCURS. MATERIAL INTENDED FOR HUMAN PHARMACEUTICAL USE BY
    INTRAMUSCULAR INJECTI ON AS PRESCRIBED BY PHYSICIAN.

=============  Exposure Controls/Personal Protection  =============

Respiratory Protection:SHOULD NOT BE NEEDED DURING NORMAL HANDLING OF
    MATERIAL.
Ventilation:NORMAL ROOM VENTILATION SHOULD BE ADEQUATE. KEEP AWAY FOR
    SPARKS OR OTHER SOURCES OF IGNITION.
Protective Gloves:SHOULD NOT BE NEEDED
Eye Protection:SHOULD NOT BE NEEDED
Other Protective Equipment:NONE SPECIFIED BY MANUFACTURER.
Work Hygienic Practices:WASH WITH SOAP AND WATER AFTER HANDLING PRODUCT
    AND BEFORE EATING DRINKING OR SMOKING.
Supplemental Safety and Health
WEAR SAFETY GLASSES WITH SIDE SHIELDS, GLOVES, LAB COAT OR OTHER
    PROTECTIVE OVERGARMENT AND NIOSH/MSHA-APPROVED HALF-FACE AIR
    PURIFYING RESPIRATOR FOR CLEAN UP OF LARGE SPILL.

==================  Physical/Chemical Properties  ==================

HCC:F4
Boiling Pt:B.P. Text:NOT GIVEN
Melt/Freeze Pt:M.P/F.P Text:NOT GIVEN
Vapor Pres:NOT GIVEN
Vapor Density:NOT GIVEN
Spec Gravity:NOT GIVEN
pH:7.6
Evaporation Rate & Reference:NOT GIVEN
Solubility in Water:NOT GIVEN
Appearance and Odor:CLEAR TO SLIGHTLY YELLOW LIQUID

=================  Stability and Reactivity Data  =================

Stability Indicator/Materials to Avoid:YES
STRONG OXIDIZING AGENTS (E.G. PERMANGANATES, NITRIC ACID)
Stability Condition to Avoid:SPARKS AND OTHER SOURCES OF IGNITION
Hazardous Decomposition Products:EMITS CARBON MONOXIDE AND CARBON
    DIOXIDE WHEN HEATED TO DECOMPOSITION.

====================  Disposal Considerations  ====================

Waste Disposal Methods:PREVENT WASTE FROM CONTAMINATING SURROUNDING
    ENVIRONMENT. DISCARD ANY PRODUCT, RESIDUE, DISPOSAL CONTAINER OR
    LINER IN ACCORDANCE WITH ALL FEDERAL, STATE AND LOCAL REGULATIONS.

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