FUJISAWA USA, INC. -- LIDOCAINE ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 00-139-4512 MSDS Date: 01/01/1994 MSDS Num: BQXRM Product ID: LIDOCAINE MFN: 01 Responsible Party Cage: 0K706 Name: FUJISAWA USA, INC. Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Info Phone Number: 708-317-0800 OR 800-888-7704 Emergency Phone Number: 708-317-0800 OR 800-888-7704 Preparer's Name: CHRISTINA J. BARRINGTON Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: 39832 Name: FUJISAWA USA, INC Address: 3 PKY N City: DEERFIELD IL 60015-2548 Phone: 847-317-1256 Cage: 0K706 Name: FUJISAWA USA, INC. Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Phone: 708-317-0800 OR 800-888-7704 ======================================================= Item Description Information ======================================================= Item Name: LIDOCAINE HYDROCHLORIDE INJECTION,USP Unit of Issue: PG UI Container Qty: 1 Type of Container: PG W/10NEEDLE ======================================================= Ingredients ======================================================= Cas: 73-78-9 Name: LIDOCAINE HYDROCHLORIDE % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 99-76-3 Name: METHYLPARABEN % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER FOR INJECTION (NOTE: PH ADJUSTED WITH HYDRCHLORIC ACID AND/OR SODIUM HYDROXIDE.) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: ORAL LD50 (RAT) IS 220 MG/KG Route Of Entry Inds - Inhalation: YES Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: EYE, SKIN AND RESPIRATORY IRRITATION MAY OCCUR. DIRECT CONTACT WITH EYES AND MUCOUS MEMBRANES MAY CAUSE SEVERE IRRITATION AS WELL AS NUMBNESS AND LOSS OF SENSATION. HYPERSENSITIVITY REACTIONS RANGING FROM MILD TO SEVERE MAY OCCUR. OTHER EFFECTS MAY INCLUDE: NERVOUSNESS, CONFUSION, DROWSINESS, VOMITING, BLURRED VISION. Explanation Of Carcinogenicity: NOT CARCINOGENIC. Signs And Symptions Of Overexposure: THIS PRODUCT IS INTENDED FOR THERAPUTIC USE ONLY WHEN PRESCRIBED BY A PHYSICIAN. POTENTIAL ADVERSE REACTIONS FROM PRESCRIBED DOSES AND OVERDOSES ARE DESCRIBED IN THE PACKAGE INSERT. OCCUPATIONAL EXPOS URE HAS NOT BEEN FULLY INVESTIGATED. Medical Cond Aggravated By Exposure: PRE-EXISTING SKIN AND RESPIRATORY CONDITIONS. First Aid: INHALATION-MOVE PERSON TO FRESH AIR IMMEDIATELY. GIVE ARTIFICIAL RESPIRATION AND CARDIOPULMONARY RESUSCITATION (CPR) IF REQUIRED. SEEK MEDICAL ATTENTION. INGESTION-FLUSH MOUTH OUT WITH WATER IMMEDIATE LY. SEEK MEDICAL ATTENTION. SKIN-REMOVECONTAMINATED CLOTHING. FLUSH AREA WITH WATER FOR AT LEAST 15 MIN. SEEK MEDICAL ATTENTION. EYE-IMMEDIATELY FLUSH WITH WATER FOR AT LEAST 15 MIN. SEEK PHYSICIAN. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: WEAR RECOMMENDED PERSONAL PROTECTOVE EQUIPMENT. USE ABSORBENT TOWELS OR BOOMS TO CLEAN-UP SPILL. WIPE SURFACE CLEAN AND WASH WITH SOAP AND WATER, Waste Disposal Methods: DISPOSE OF IN ACCORDANCE WITH FEDERAL, STATE AND LOCAL REGULATIONS. Handling And Storage Precautions: WHEN HANDLING PHARMACEUTICAL PRODUCTS, AVOID ALL CONTACT AND INHALATION OF DUST, FUMES, MIST, AND/OR VAPOR ASSOCIATED WITH THE PRODUCT. Other Precautions: FOR ADVERSE DRUG REACTION INFORMATION CALL (708) 317-5937. ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Method: CC Flash Point Text: >200F,>93C Extinguishing Media: WATER SPRAY, DRY CHEMICAL, CARBON DIOXIDE OR FOAM AS APPROPIATE. Fire Fighting Procedures: WEAR SELF-CONTAINED BREATHING APPARATUS AND PROTECTIVE CLOTHING. Unusual Fire/Explosion Hazard: WHEN HEATED TO DECOMPOSITION IT EMITS TOXIC FUMES ======================================================= Control Measures ======================================================= Respiratory Protection: WITH SATISFACTORY VENTILATION, RESPIRATORY PROTECTION NOT USUALLY REQUIRED. Ventilation: GENERAL ROOM VENTILATION IS USUALLY SATISFACTORY, USE LOCAL EXHAUST VENTILATION WHEN NECESSARY. Protective Gloves: DISPOSABLE LATEX GLOVES RECOMMENDED. Eye Protection: SAFETY GLASSES OR GOGGLES RECOMMENDED. Other Protective Equipment: DISPOSABLE GARMETS IF DIRECT SKIN CONTACT IS ANTICIPATED. Work Hygienic Practices: NONE SPECIFIED BY MANUFACTURER. Supplemental Safety and Health: NONE. ======================================================= Physical/Chemical Properties ======================================================= HCC: C3 PH: 5.0-7 Solubility in Water: FREELY SOLUBLE HCL. Appearance and Odor: CLEAR, COLORLESS, ODORLESS SOLUTION. ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: NONE. Materials To Avoid: NONE. Hazardous Decomposition Products: SMOKE AND NOX FUMES. Hazardous Polymerization Indicator: NO Conditions To Avoid Polymerization: NONE. ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: 0K706 Trans ID NO: 49813 Product ID: LIDOCAINE MSDS Prepared Date: 01/01/1994 Review Date: 07/01/1993 MFN: 1 Net Unit Weight: 1.4 LB Multiple KIT Number: 0 Review IND: Y Unit Of Issue: PG Container QTY: 1 Type Of Container: PG W/10NEEDLE ======================================================= 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: LIDOCAINE Cage: 0K706 Company Name: FUJISAWA USA, INC. Street: 3 PARKWAY NORTH City: DEERFIELD IL Zipcode: 60015-2548 Health Emergency Phone: 708-317-0800, 800-888-7704 Label Required IND: Y Date Of Label Review: 07/01/1993 Status Code: C Label Date: 07/01/1993 Origination Code: F Eye Protection IND: YES Skin Protection IND: YES Signal Word: CAUTION Respiratory Protection IND: YES Health Hazard: Slight Contact Hazard: Slight Fire Hazard: Slight Reactivity Hazard: None Hazard And Precautions: EYE,SKIN,RESPIRATORY IRRITATION,UNUSUALLY SLOW HEARTBEAT,DIFFICULTY BREATHING,SWELLING MAY OCCUR.PRODUCT INTENDED FOR THERAPUTIC USE ONLY WHEN PRESCRIBED BY A PHYSICIAN.POTENTIAL ADVERSE REACTIONS FRO M PRESCRIBED DOSES AND OVERDOSES ARE DESCRIBED IN PACKAGE INSERT. FIRST AID: EYES: FLUSH WITH LARGE AMOUNTS OF WATER. GET MEDICAL ATTENTION. SKIN: REMOVE CONTAMINATED CLOTHING. FLUSH AREA WITH LARGE A MOUNTS OF WATER. GET MEDICAL ATTENTION. INHALATION: MOVE TO FRESH AIR. IF NOT BREATHING GIVE CPR. GET MEDICAL ATTENTION. INGESTION: FLUSH MOUTH OUT WITH WATER IMMEDIATELY. GET MEDICAL ATTENTION. GENER AL: FOR ADDITIONAL INFORMATION SEE PRODUCT INSERT. ======================================================= 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.