LILLY ELI & PHARMACEUTICAL DIV -- MS5120 FLUOXETINE HYDROCHLORIDE ORAL SOLUTION ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 01-362-5333 MSDS Date: 07/20/1993 MSDS Num: BYPFW Product ID: MS5120 FLUOXETINE HYDROCHLORIDE ORAL SOLUTION MFN: 01 Responsible Party Cage: GO399 Name: LILLY ELI & CO PHARMACEUTICAL DIV Address: 307 E MCCARTY ST City: INDIANAPOLIS IN 48285-5000 Info Phone Number: 317-276-2000/317-276-3494 Emergency Phone Number: 317-276-2000/317-276-3494 Review Ind: Y Published: Y ======================================================= Preparer Co. when other than Responsible Party Co. ======================================================= Cage: GO399 Assigned Ind: Y Name: LILLY ELI & CO PHARMACEUTICAL DIV Address: LILLY CORPORATE CENTER City: INDIANAPOLIS IN 46285 ======================================================= Contractor Summary ======================================================= Cage: GO399 Name: LILLY ELI & CO PHARMACEUTICAL DIV Address: LILLY CORPORATE CENTER City: INDIANAPOLIS IN 46285 Phone: 317-276-2000 Cage: 75602 Name: LILLY ELI AND CO PHARMACEUTICAL DIV Address: LILLY CORPORATE CENTER City: INDIANAPOLIS IN 46285 Phone: 317-276-2000 ======================================================= Item Description Information ======================================================= Item Name: FLUOXETINE HYDROCHLORIDE SOLUTION ======================================================= Ingredients ======================================================= Cas: 59333-67-4 Name: FLUOXETINE HYDROCHLORIDE % Wt: 0.35 ----------------------------- Cas: 57-50-1 RTECS #: WN6500000 Name: SUCROSE % Wt: 47 ACGIH TLV: 10 MG/CUM ------------------------------ Cas: 56-81-5 RTECS #: MA8050000 Name: GLYCERINE, 1,2,3,-TRIHYDROXYPROPANE, GLYCEROL, ANHYDROUS GLYCERINE, GLYCERIN *95-4* % Wt: 15 ACGIH TLV: 10 MG/CUM (VAPOR) ------------------------------ Cas: 64-17-5 RTECS #: KQ6300000 Name: ETHANOL (ETHYL ALCOHOL), TECSOL, ALCOHOL, SYNASOL % Wt: 0.23 Other REC Limits: 1900 MG/CUM OSHA PEL: 1000 PPM ACGIH TLV: 1000 PPM ------------------------------ Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER % Wt: 36 ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: ORAL LD50(RAT): 0.5 ML/KG Route Of Entry Inds - Inhalation: YES Skin: NO Ingestion: NO Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: SKIN: CONTACT DERMATITIS HAS BEEN REPORTED W/OCCUPATIONAL EXPOSURE TO FLUOXETINE HYDROCHLORIDE. OVERDOSE AFTER SUSTAINED THERAPEUTIC EXPOSURE TO FLUOXETINE HYDROCHLORIDE HAS RESULTED IN SEIZURES. Explanation Of Carcinogenicity: NONE Signs And Symptions Of Overexposure: CONTACT DERMATITIS HAS BEEN REPORTED W/OCCUPATIONAL EXPOSURE TO FLUOXETINE HYDROCHLORIDE. OVERDOSE AFTER SUSTAINED THERAPEUTIC EXPOSURE TO FLUOXETINE HYDROCHLORIDE HAS RESULTED IN SEIZURES. Medical Cond Aggravated By Exposure: SEIZURE DISORDER First Aid: EYES: FLUSH W/PLENTY OF WATER. SKIN: WASH W/SOAP & WATER. INHALATION: REMOVE TO FRESH AIR. GIVE CPR IF NEEDED. INGESTION: DON'T INDUCE VOMITING. IF AVAILABLE, ADMINISTER ACTIVATED CHARCOAL (6-8 HEAPIN G TEASPOONS) W/2-3 GLASSES OF WATER. DON'T GIVE ANYTHING BY MOUTH TO AN UNCONSIOUS PERSON. OBTAIN MEDICAL ATTENTION IN ALL CASES. (SEE SUPP) ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: PREVENT FURTHER MIGRATION INTO ENVIRONMENT. USE ABSORBENT/ADSORBENT MATERIAL TO SOLIDIFY LIQUIDS. WEAR PROTECTIVE EQUIPMENT, INCLUDING EYE PROTECTION. Waste Disposal Methods: DISPOSE OF IAW/FEDERAL, STATE & LOCAL REGULATIONS. Handling And Storage Precautions: UNDER NORMAL USE & HANDLING CONDITIONS, NO PROTECTIVE EQUIPMENT IS REQUIRED. ======================================================= Fire and Explosion Hazard Information ======================================================= Extinguishing Media: WATER, CO2, DRY CHEMICAL, FOAM/HALON. ======================================================= Control Measures ======================================================= Respiratory Protection: USE AN APPROVED RESPIRATOR Ventilation: LABORATORY FUME HOOD/LOCAL EXHAUST VENTILATION. Protective Gloves: CHEMICAL-RESISTANT Eye Protection: SAFETY GLASSES Other Protective Equipment: CHEMICAL-RESISTANT BODY COVERING. THE FOLLOWING PROTECTION EQUIPMENT IS RECOMMENDED FOR A PRODUCTION SETTING. Work Hygienic Practices: REMOVE/LAUNDER CONTAMINATED CLOTHING BEFORE REUSE. Supplemental Safety and Health: APPROPRIATE SEIZURE PRECAUTIONS ARE ADVISED FOR ANY PATIENT REGULARLY TAKING PROZAC WHO HAS BEEN EXPOSED TO AN ACUTE OVERDOSE. ======================================================= Physical/Chemical Properties ======================================================= Spec Gravity: 1.2-1.3 PH: 2.5-5 Solubility in Water: COMPLETE Appearance and Odor: CLEAR COLORLESS SOLUTION W/MINT-LIKE ODOR. ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Materials To Avoid: STRONG OXIDIZING AGENTS Hazardous Decomposition Products: WHEN HEATED, MAY EMIT TOXIC FUMES. Hazardous Polymerization Indicator: NO ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= HAZCOM Label ======================================================= Product ID: MS5120 FLUOXETINE HYDROCHLORIDE ORAL SOLUTION Cage: GO399 Assigned IND: Y Company Name: LILLY ELI & CO PHARMACEUTICAL DIV Street: LILLY CORPORATE CENTER City: INDIANAPOLIS IN Zipcode: 46285 Health Emergency Phone: 317-276-2000/317-276-3494 Label Required IND: Y Date Of Label Review: 12/16/1998 Status Code: C Label Date: 12/16/1998 Origination Code: G Hazard And Precautions: SKIN: CONTACT DERMATITIS HAS BEEN REPORTED W/OCCUPATIONAL EXPOSURE TO FLUOXETINE HYDROCHLORIDE. OVERDOSE AFTER SUSTAINED THERAPEUTIC EXPOSURE TO FLUOXETINE HYDROCHLORIDE HAS RESULTED IN SEIZURES. CONTACT DERMATITIS HAS BEEN REPORTED W/OCCUPATIONAL EXPOSURE TO FLUOXETINE HYDROCHLORIDE. OVERDOSE AFTER SUSTAINED THERAPEUTI C EXPOSURE TO FLUOXETINE HYDROCHLORIDE HAS RESULTED IN SEIZURES. ======================================================= 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.