SIDMAK LABORATORIES, INC -- INDOMETHACIN CAPSULES,USP 25 MG ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 00-931-0680 MSDS Date: 01/02/1995 MSDS Num: CDYWN Product ID: INDOMETHACIN CAPSULES,USP 25 MG MFN: 01 Responsible Party Cage: 1BL76 Name: SIDMAK LABORATORIES, INC Address: 17 WEST ST Box: 371 City: EAST HANOVER NJ 07936-2822 Info Phone Number: 201-386-0547 Emergency Phone Number: 201-386-5566 Preparer's Name: UNKNOWN Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: 1BL76 Name: SIDMAK LABORATORIES, INC Address: 17 WEST ST Box: 371 City: EAST HANOVER NJ 07936-2822 Phone: 201-386-5566 ======================================================= Item Description Information ======================================================= Item Manager: S9M Item Name: INDOMETHACIN CAPSULES,USP Specification Number: NONE Type/Grade/Class: NONE Unit of Issue: BT UI Container Qty: 1.67 LBS Type of Container: BOTTLE ======================================================= Ingredients ======================================================= Cas: 53-86-1 RTECS #: NL3500000 Name: INDOMETHACIN % Wt: 8.87 Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ----------------------------- RTECS #: 1009114IA Name: INACTIVES % Wt: 91.13 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: NO Skin: NO Ingestion: NO Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: TARGET ORGANS:NONE. ACUTE AND CHRONIC- EYE/SKIN/INHALATION:EXPOSURE NOT LIKELY DUE TO THE PHYSICAL FORM OF THE CAPSULE. ORAL:UNKNOWN. Explanation Of Carcinogenicity: NONE Signs And Symptions Of Overexposure: UNKNOWN Medical Cond Aggravated By Exposure: UNKNOWN First Aid: EYE/SKIN/INHALATION:NOT RELEVANT. ORAL:CALL PHYSICIAN IMMEDIATELY. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: COLLECT SPILLED CAPSULES AND PLACE INTO CLOSED CONTAINER FOR REUSE OR DISPOSAL. Neutralizing Agent: NOT RELEVANT Waste Disposal Methods: DISPOSE OF IN ACCORDANCE WITH LOCAL, STATE AND FEDERAL REGULATIONS. Handling And Storage Precautions: STORE AT CONTROLED ROOM TEMPERATURES 15-30C (59-86F) IN A WELL-CLOSED CONTAINER AS DEFINED IN THE USP. KEEP OUT OF REACH OF CHILDREN. Other Precautions: AS A GENERAL RULE, WHEN HANDLING PHARMACEUTICAL ORLABORATORY PRODUCTS, AVOID ALL FORMS OF CONTACT AND INHALATION OF DUST,FUMES, MISTS, AND/OR VAPORS ASSOCIATED WITH THE PRODUCT. WASH THOROUGHLYAFTER HANDLING AND BEFORE EATING OR DRINKING ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Text: NONE Lower Limits: NOT RELEVANT Upper Limits: NOT RELEVANT Extinguishing Media: WATER SPRAY, CARBON DIOXIDE, FOAM OR DRY CHEMICAL FOR SURROUNDING FIRE. USE WATER SPRAY TO COOL FIRE EXPOSED CONTAINERS. Fire Fighting Procedures: WEAR PROTECTIVE CLOTHING AND NIOSH-APPROVED SELF-CONTAINED BREATHING APPARATUS. Unusual Fire/Explosion Hazard: NONE ======================================================= Control Measures ======================================================= Respiratory Protection: NONE SHOULD BE NEEDED. Ventilation: NORMAL Protective Gloves: NONE Eye Protection: NONE Other Protective Equipment: NONE Work Hygienic Practices: OBSERVE GOOD PERSONAL HYGIENE PRACTICES AND RECOMMENDED PROCEDURES. ======================================================= Physical/Chemical Properties ======================================================= HCC: N1 NRC/State LIC No: NOT RELEVANT M.P/F.P Text: NOT KNOWN Decomp Text: NOT KNOWN Spec Gravity: UNKNOWN Viscosity: NOT RELEVANT Evaporation Rate & Reference: NOT RELEVANT Solubility in Water: UNKNOWN Appearance and Odor: OPAQUE GREEN BODY AND CAP IN A HARD GELATIN CAPSULE SIZE 3 ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: HIGH HEAT Materials To Avoid: NONE Hazardous Decomposition Products: NONE Hazardous Polymerization Indicator: NO Conditions To Avoid Polymerization: NOT RELEVANT ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: 1BL76 Trans ID NO: 92831 Product ID: INDOMETHACIN CAPSULES,USP 25 MG MSDS Prepared Date: 01/02/1995 Review Date: 06/26/1997 MFN: 1 Radioactivity: NOT RELEVANT Net Unit Weight: 1.67 LBS DOD Exemption NUM: NOT RELEVANT Multiple KIT Number: 0 Review IND: Y Unit Of Issue: BT Container QTY: 1.67 LBS Type Of Container: BOTTLE Additional Data: NOT REGULATED, PER MSDS. ======================================================= 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: INDOMETHACIN CAPSULES,USP 25 MG Cage: 1BL76 Company Name: SIDMAK LABORATORIES, INC Street: 17 WEST ST PO Box: 371 City: EAST HANOVER NJ Zipcode: 07936-2822 Health Emergency Phone: 201-386-5566 Date Of Label Review: 06/26/1997 Status Code: C Label Date: 06/26/1997 Origination Code: Z ======================================================= 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.