SANOFI WINTHROP INC. -- 187 8297 MARCAINE(R) HYDROCHLORIDE 0.5% WITH ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 01-189-3973 MSDS Date: 04/24/1996 MSDS Num: CDKQN Product ID: 187 8297 MARCAINE(R) HYDROCHLORIDE 0.5% WITH EPINEPHRINE MFN: 01 Responsible Party Cage: 0X8A4 Name: SANOFI WINTHROP INC. Address: 90 PARK AVETREET City: NEW YORK NY 10016 Info Phone Number: 800-242-2424 MSDS:800-242-2424EXT25 Emergency Phone Number: 800-933-8031 Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: 19139 Name: EASTMAN KODAK COMPANY Address: 343 STATE STREET City: ROCHESTER NY 14650 Phone: 716-722-5151/(800) 242-2424 Cage: 5K871 Name: EASTMAN KODAK COMPANY, EASTERN REGIONAL DIST. CTR. Address: 1187 W RIDGE RD City: ROCHESTER NY 14650 Phone: 716-722-5151 Cage: 0X8A4 Name: SANOFI WINTHROP INC. Address: 90 PARK AVE City: NEW YORK NY 14650 Phone: 800-242-2424 ======================================================= Item Description Information ======================================================= Item Manager: S9G Item Name: BUPIVACAINE AND EPINEPHRINE INJECTION Unit of Issue: CN ======================================================= Ingredients ======================================================= Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER % Wt: 95-99 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 50-81-7 RTECS #: CI7650000 Name: ASCORBIC ACID % Wt: < 1 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT EXTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 7681-57-4 RTECS #: UX8225000 Name: SODIUM METABISULFITE % Wt: < 1 Other REC Limits: NONE RECOMMENDED OSHA PEL: 5 MG/M3 ACGIH TLV: 5 MG/M3; 9596 ------------------------------ Cas: 62-33-9 RTECS #: EV7700000 Name: ETHYLENEDIAMINETETRAACETIC ACID; CALCIUM DISODIUM SALT % Wt: < 1 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 51-42-3 RTECS #: DO3500000 Name: EPINEPHRINE BITARTRATE % Wt: < 1 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 18910-40-7 RTECS #: 1010575BU Name: BUPIVACAINE HYDROCHLORIDE % Wt: < 1 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: ORAL LD50 (RAT): NOT GIVEN Route Of Entry Inds - Inhalation: NO Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: ABSORBED THROUGH THE MUCOUS MEMBRANES PRODUCT CAN CAUSE LOCAL ANESTHESIA. MAY CAUSE CHANGES IN HEART RATE AND BLOOD PRESSURE, FAINTNESS, SWEATING, CNS EFFECTS. LOW INHALATION HAZARD EXPECTED WITH NORMAL USE. EYE CONTACT MAY CAUSE TRANSIENT IRRITATION. HARMFUL IF ABSORBED THROUGH THE SKIN. HARMFUL IF SWALLOWED. Explanation Of Carcinogenicity: THIS COMPOUND CONTAINS NO INGREDIENTS AT CONCENTRATIONS OF 0.1% OR GREATER THAT ARE CARCINOGENS OR SUSPECT CARCINOGENS. Signs And Symptions Of Overexposure: NUMBNESS IN EXPOSED AREA, CHANGES IN HEART RATE AND BLOOD PRESSURE, FAINTNESS, SWEATING, DIZZINESS, NERVOUSNESS, DROWSINESS, BLURRED VISION, TREMORS, EYE IRRITATION. Medical Cond Aggravated By Exposure: ADVERSE EFFECTS COULD BE MORE PRONOUNCED IN THOSE RECEIVING MEDICATIONS TO ALTER BLOOD PRESSURE AND PEOPLE WITH CARDIOVASCULAR DISEASE OR DRUG SENSITIVITY OR ALLERGY. First Aid: INHALATION: IF SYMPTOMATIC, MOVE TO FRESH AIR. GET MEDICAL ATTENTION IF SYMPTOMS PERSIST. EYES: WASH OUT IMMEDIATELY WITH WATER. GET MEDICAL ATTENTION IF SYMPTOMS OCCUR. SKIN: WASH WITH SOAP AND WATER. GET MEDICAL ATTENTION IF SYMPTOMS OCCU R. INGESTION: ONLY INDUCE VOMITING AT THE INSTRUCTION OF MEDICAL PERSONNEL. NEVER GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. CALL PHYSICIAN ASAP. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: FLUSH TO SEWER IF ALLOWABLE WITH LARGE AMOUNTS OF WATER. OTHERWISE, ABSORB SPILL WITH VERMICULITE OR OTHER INERT MATERIAL, THEN PLACE IN A CONTAINER FOR CHEMICAL WASTE. CLEAN SURFACE TO REMOVE RESIDUAL CONTAMINATION. Neutralizing Agent: NONE SPECIFIED BY MANUFACTURER. Waste Disposal Methods: DISCHARGE, TREATMENT OR DISPOSAL MAY BE SUBJECT TO NATIONAL, STATE OR LOCAL LAWS. MAY REQUIRE NEUTRALIZATION IF PH < 2.0 OR PH > 12.5. DISPOSE OF IN ACCORDANCE WITH ALL APPLICABLE FEDERAL, STATE AND LOCAL REGULATIONS. Handling And Storage Precautions: AVOID CONTACT WITH EYES, SKIN AND CLOTHING. USE WITH ADEQUATE VENTILATION. WASH THOROUGHLY AFTER HANDLING. KEEP CONTAINER TIGHTLY CLOSED. Other Precautions: NONE SPECIFIED BY MANUFACTURER. ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Text: NONFLAMMABLE Lower Limits: NOT GIVEN Upper Limits: NOT GIVEN Extinguishing Media: USE APPROPRIATE AGENT FOR ADJACENT FIRE. Fire Fighting Procedures: WEAR SELF-CONTAINED BREATHING APPARATUS AND PROTECTIVE CLOTHING. Unusual Fire/Explosion Hazard: NONE SPECIFIED BY MANUFACTURER. ======================================================= Control Measures ======================================================= Respiratory Protection: NONE SHOULD BE NEEDED. Ventilation: GOOD GENERAL VENTILATION, TYPICALLY 10 AIR CHANGES PER HOUR, SHOULD BE USED. RATES SHOULD MATCH CONDITIONS. Protective Gloves: IMPERVIOUS Eye Protection: SAFETY GLASSES W/SIDE SHIELDS OR GOGGLES Other Protective Equipment: CHEMICAL RESISTANT CLOTHING AS NECESSARY TO PREVENT SKIN CONTACT. AN EMERGENCY EYEWASH AND SHOWER SHOULD BE AVAILABLE. Work Hygienic Practices: WASH HANDS THOROUGHLY WITH SOAP AND WATER BEFORE EATING, DRINKING, SMOKING OR USING TOILET FACILITIES. Supplemental Safety and Health: REMOVE AND WASH CONTAMINATED CLOTHING BEFORE REUSE. ======================================================= Physical/Chemical Properties ======================================================= HCC: T6 B.P. Text: >212F,>100C M.P/F.P Text: NOT GIVEN Decomp Text: UNKNOWN Vapor Pres: 18 Vapor Density: 0.6 Spec Gravity: NOT GIVEN Viscosity: NOT GIVEN Evaporation Rate & Reference: NOT GIVEN Solubility in Water: COMPLETE Appearance and Odor: COLORLESS LIQUID, ODOR NOT SPECIFIED Percent Volatiles by Volume: 97% Corrosion Rate: UNKNOWN ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: NONE SPECIFIED BY MANUFACTURER. Materials To Avoid: NONE WITH COMMON MATERIALS AND CONTAMINANTS WITH WHICH THE MATERIAL MAY REASONABLY COME INTO CONTACT. Hazardous Decomposition Products: NONE SPECIFIED BY MANUFACTURER. Hazardous Polymerization Indicator: NO Conditions To Avoid Polymerization: NONE. WILL NOT OCCUR. ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: 0X8A4 Trans ID NO: 113887 Product ID: 187 8297 MARCAINE(R) HYDROCHLORIDE 0.5% WITH EPINEPHRINE MSDS Prepared Date: 04/24/1996 Review Date: 03/27/1997 MFN: 1 Multiple KIT Number: 0 Review IND: Y Unit Of Issue: CN ======================================================= Detail DOT Information ======================================================= DOT PSN Code: ZZZ DOT Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= Detail IMO Information ======================================================= IMO PSN Code: ZZZ IMO Proper Shipping Name: NOT REGULATED FOR THIS MODE OF TRANSPORTATION ======================================================= Detail IATA Information ======================================================= IATA PSN Code: ZZZ IATA Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= Detail AFI Information ======================================================= AFI PSN Code: ZZZ AFI Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= HAZCOM Label ======================================================= Product ID: 187 8297 MARCAINE(R) HYDROCHLORIDE 0.5% WITH EPINEPHRINE Cage: 0X8A4 Assigned IND: Y Company Name: SANOFI WINTHROP INC. Street: 90 PARK AVE City: NEW YORK NY Zipcode: 14650 Health Emergency Phone: 800-933-8031 Label Required IND: Y Date Of Label Review: 03/27/1997 Status Code: C MFG Label NO: NONE Label Date: 03/27/1997 Origination Code: G Eye Protection IND: YES Skin Protection IND: YES Signal Word: WARNING Health Hazard: Moderate Contact Hazard: Moderate Fire Hazard: None Reactivity Hazard: None Hazard And Precautions: HARMFUL IF ABSORBED THROUGH THE SKIN. PRODUCT MAY BE ABSORBED THROUGH THE MUCOUS MEMBRANES AND CAUSE LOCAL ANESTHESIA. AVOID CONTACT WITH EYES, SKIN AND CLOTHING. USE WITH ADEQUATE VENTILATION. WASH THOROUGHLY AFTER HANDLING. KEEP CONTAINER TIGHTLY CLOSED. FIRST AID: INHALATION: IF SYMPTOMATIC, MOVE TO FRESH AIR. GET MEDICAL ATTENTION IF SYMPTOMS PERSIST. EYES: WASH OUT IMMEDIATELY WITH WATER. GET MEDICAL ATTENTION IF SYMPTOMS OCCUR. SKIN: WASH WITH SOAP AND WATER. GET MEDICA L ATTENTION IF SYMPTOMS OCCUR. INGESTION: ONLY INDUCE VOMITING AT THE INSTRUCTION OF MEDICAL PERSONNEL. NEVER GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. CALL MD. ======================================================= Disclaimer (provided with this information by the compiling agencies): This information is formulated for use by elements of the Department of Defense. The United States of America in no manner whatsoever expressly or implied warrants, states, or intends said information to have any application, use or viability by or to any person or persons outside the Department of Defense nor any person or persons contracting with any instrumentality of the United States of America and disclaims all liability for such use. Any person utilizing this instruction who is not a military or civilian employee of the United States of America should seek competent professional advice to verify and assume responsibility for the suitability of this information to their particular situation regardless of similarity to a corresponding Department of Defense or other government situation.