FUJISAWA USA INC. -- OXYTOCIN INJECTION ======================================================= MSDS Safety Information ======================================================= FSC: 6505 MSDS Date: 01/01/1994 MSDS Num: BTRHC LIIN: 00F034719 Product ID: OXYTOCIN INJECTION MFN: 01 Responsible Party Cage: 24832 Name: FUJISAWA USA INC. Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Info Phone Number: 708-317-8800 Emergency Phone Number: 708-317-8800 Preparer's Name: CHRISTINA J. BARRINGTON Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: 24832 Name: FUJISAWA USA INC (LYPHOMED INC) Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Phone: 800-727-7003/708-317-8800 Cage: 0K706 Name: FUJISAWA USA, INC. Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Phone: 708-317-0800 OR 800-888-7704 ======================================================= Ingredients ======================================================= Cas: 57-15-8 RTECS #: UC0175000 Name: 1,1,1-TRICHLORO-2-METHYL-2-PROPANOL % Wt: 0.5 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 50-56-6 Name: OXYTOCIN % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER - PH ADJUSTED % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: LD50 (ORAL RAT) IS UNKNOWN Route Of Entry Inds - Inhalation: YES Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: 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. Explanation Of Carcinogenicity: THIS PRODUCT IS NOT LISTED BY NTP, IARC, OR OSHA Signs And Symptions Of Overexposure: IMMEDIATE EFFECTS:EYE, SKIN, RESPIRATORY IRRITATION MAY OCCUR. DELAYED EFFECTS:"NONE KNOWN" Medical Cond Aggravated By Exposure: PRE-EXISTING SKIN & RESPIRATORY CONDITIONS First Aid: EYE:FLUSH W/WATER 15 MIN. SEEK MEDICAL ATTENTION. SKIN:REMOVE CONTAMINATED CLOTHING IMMEDIATELY. FLUSH AREA W/WATER FOR 15 MIN. SEEK MEDICAL ATTENTION. INHALED:REMOVE TO FRESH AIR. AID/RESTORE BREA THING IF NECESSARY. SEEK MEDICAL ATTENTION. INGESTED:FLUSH OUT MOUTH WITH WATER IMMEDIATELY. SEEK MEDICAL ATTENTION. FOR ADVERSE DRUG REACTION INFORMATION CALL 708-317-5937. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: WEAR RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT. USE ABSORBENT TOWELS OR BOOMS TO CLEAN UP SPILL. WIPE SURFACES CLEAN AND WASH WITH SOAP AND WATER. Neutralizing Agent: NO INFORMATION GIVEN ON MSDS BY MFR. 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 VAPORS ASSOCIATED WITH THE PRODUCT. Other Precautions: NONE ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Method: CC Flash Point Text: >200F,>93C Lower Limits: UNKNOWN Upper Limits: UNKNOWN Extinguishing Media: WATER SPRAY, DRY CHEMICAL, CARBON DIOXIDE OR FOAM AS APROPIATE. Fire Fighting Procedures: WEAR SELF-CONTAINED BREATHING APPARATUS AND PROTECTIVE CLOTHING. Unusual Fire/Explosion Hazard: GENERAL 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 GRAMENTS IF DIRECT SKIN CONTACT IS ANTICIPATED. Work Hygienic Practices: MFR: ? :USE GOOD CHEMICAL HYGIENE PRACTICE. AVOID ALL UNNECESSARY EXPOSURE. WASH THOROUGHLY BEFORE EATING OR DRINKI Supplemental Safety and Health: NONE ======================================================= Physical/Chemical Properties ======================================================= HCC: N1 NRC/State LIC No: NONE Net Prop WT For Ammo: NONE B.P. Text: UNKNOWN M.P/F.P Text: UNKNOWN Decomp Text: UNKNOWN Vapor Pres: UNKNOWN Vapor Density: UNKNOWN Spec Gravity: UNKNOWN PH: 2.5-5 Evaporation Rate & Reference: UNKNOWN Solubility in Water: SOLUBLE Appearance and Odor: CLEAR COLORLESS ODORLESS SOLUTION Corrosion Rate: UNKNOWN ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: DO NOT PERMIT TO FREEZE. Materials To Avoid: NONE Hazardous Decomposition Products: HAZARDOUS COMBUSTION PRODUCTS:SMOKE AND NOX FUMES Hazardous Polymerization Indicator: NO Conditions To Avoid Polymerization: WILL NOT OCCUR. ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: 24832 Trans ID NO: 8937 Product ID: OXYTOCIN INJECTION MSDS Prepared Date: 01/01/1994 Review Date: 07/07/1994 MFN: 1 AF MMAC Code: NR Multiple KIT Number: 0 Review IND: Y Additional Data: PROPER SHIPPING NAME SUPPLIED BY MFR. ======================================================= 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: OXYTOCIN INJECTION Cage: 24832 Company Name: FUJISAWA USA INC (LYPHOMED INC) Street: 3 PARKWAY NORTH City: DEERFIELD IL Zipcode: 60015-2548 Health Emergency Phone: 708-317-8800 Date Of Label Review: 07/07/1994 Status Code: C Label Date: 07/07/1994 Origination Code: Z Hazard And Precautions: LABEL FOR THIS PRODUCT IS SPECIFIED BY THE FDA, NOT OSHA! ======================================================= 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.