AMERICAN REAGENT LABS-LUITPOLD -- DEXAMETHASONE SODIUM PHOSPHATE INJECTION ======================================================= MSDS Safety Information ======================================================= FSC: 6505 MSDS Date: 05/04/1992 MSDS Num: BXKXS LIIN: 00F040081 Product ID: DEXAMETHASONE SODIUM PHOSPHATE INJECTION MFN: 01 Responsible Party Cage: GO406 Name: AMERICAN REAGENT LABS-LUITPOLD PHARMACEUTICALS INC Address: 1 LUTTPOLD DR City: SHIRLEY NY 11967-5000 Info Phone Number: 516-924-4000/800-645-1706 Emergency Phone Number: 516-924-4000/800-645-1706 Preparer's Name: JOHN PURPURA Review Ind: Y Published: Y ======================================================= Preparer Co. when other than Responsible Party Co. ======================================================= Cage: GO406 Assigned Ind: Y Name: AMERICAN REAGENT LABS-LUITPOLD PHARMACEUTICALS INC Address: 1 LUTTPOLD DR City: SHIRLEY NY 11967-5000 ======================================================= Contractor Summary ======================================================= Cage: GO406 Name: AMERICAN REAGENT LABS-LUITPOLD PHARMACEUTICALS INC Address: 1 LUTTPOLD DR City: SHIRLEY NY 11967-5000 Phone: 516-924-4000/800-645-1706 Cage: 32288 Name: AMERICAN REGENT - LUITPOLD PHARMACEUTICALS INC Address: 1 LUITPOLD DR City: SHIRLEY NY 11967-5000 Phone: 516-924-4000/800-645-1706 ======================================================= Ingredients ======================================================= Cas: 2392-39-4 RTECS #: TU4056000 Name: DEXAMETHASONE SODIUM PHOSPHATE ------------------------------ Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER ======================================================= Health Hazards Data ======================================================= Route Of Entry Inds - Inhalation: YES Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: EYES, SKIN/RESPIRATORY TRACT IRRITATION. SUPPRESSION OF ADRENAL GLAND SECRETION, HYPERGLYCEMIA, WATER RETENTION. POSSIBLE HYPERSENSITIZATION. Explanation Of Carcinogenicity: NONE Signs And Symptions Of Overexposure: EYES, SKIN/RESPIRATORY TRACT IRRITATION. SUPPRESSION OF ADRENAL GLAND SECRETION, HYPERGLYCEMIA, WATER RETENTION. POSSIBLE HYPERSENSITIZATION. First Aid: INHALATION: REMOVE TO FRESH AIR. INGESTION: FLUSH MOUTH OUT W/WATER. SKIN/EYES: FLUSH W/WATER. OBTAIN MEDICAL ATTENTION IN ALL CASES. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: WEAR PERSONAL PROTECTIVE EQUIPMENT. VACUUM W/A VACUUM CLEANER HAVING A HIGH EFFICIENCY PARTICULATE (HEPA) FILTER/ABSORB LIQUID W/PAPER TOWELS. WIPE WORKING SURFACES TO DRYNESS, THEN WASH W/SOAP & WATE R. Waste Disposal Methods: WASTE SHOULD BE DISPOSED OF IN ACCORDANCE W/LOCAL, STATE & FEDERAL REGULATIONS. DON'T MIX W/OTHER SUBSTANCES. Handling And Storage Precautions: DON'T MIX W/OTHER DRUGS. Other Precautions: AVOID ALL CONTACT & INHALATION OF DUST, FUMES, MIST/VAPORS ASSOCIATED W/THE PRODUCT. ======================================================= Fire and Explosion Hazard Information ======================================================= Extinguishing Media: WATER SPRAY, CO2, DRY CHEMICAL/FOAM AS APPROPRIATE FOR SURROUNDING FIRE & MATERIALS Fire Fighting Procedures: USE SELF CONTAINED BREATHING APPARATUS & PROTECTIVE CLOTHING. Unusual Fire/Explosion Hazard: EMITS TOXIC FUMES. ======================================================= Control Measures ======================================================= Respiratory Protection: NIOSH APPROVED RESPIRATOR Ventilation: LOCAL EXHAUST Protective Gloves: DISPOSABLE SURGICAL LATEX Eye Protection: SAFETY GOGGLES Other Protective Equipment: DISPOSABLE PROTECTIVE APPAREL Work Hygienic Practices: REMOVE/LAUNDER CONTAMINATED CLOTHING BEFORE REUSE. Supplemental Safety and Health: DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP IS A STERILE, NONPYROGENIC SOLUTION OF DEXAMETHASONE SODIUM PHOSPHATE IN WATER FOR INJECTION. ======================================================= Physical/Chemical Properties ======================================================= PH: 7-8.5 Solubility in Water: COMPLETE Appearance and Odor: CLEAR COLORLESS TO PALE YELLOW SOLUTION W/NO ODOR ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: EXCESSIVE HEAT & LIGHT Materials To Avoid: MIXING W/OTHER DRUGS Hazardous Decomposition Products: TOXIC FUMES Hazardous Polymerization Indicator: NO ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= HAZCOM Label ======================================================= Product ID: DEXAMETHASONE SODIUM PHOSPHATE INJECTION Cage: GO406 Assigned IND: Y Company Name: AMERICAN REAGENT LABS-LUITPOLD PHARMACEUTICALS INC Street: 1 LUTTPOLD DR City: SHIRLEY NY Zipcode: 11967-5000 Health Emergency Phone: 516-924-4000/800-645-1706 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: EYES, SKIN/RESPIRATORY TRACT IRRITATION. SUPPRESSION OF ADRENAL GLAND SECRETION, HYPERGLYCEMIA, WATER RETENTION. POSSIBLE HYPERSENSITIZATION. EYES, SKIN/RESPIRATORY TRACT IRRITATION. SUPPRESSION OF ADRENAL GLAND SECRETION, HYPERGLYCEMIA, WATER RETENTION. POSSIBLE HYPERSENSITIZATION. ======================================================= 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.