GLAXO WELCOME INC. -- LANOXIN ELIXIR AND INJECTION,NDC 00081-0260-1 ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 00-531-7761 MSDS Date: 10/31/1994 MSDS Num: BZLGX Product ID: LANOXIN ELIXIR AND INJECTION,NDC 00081-0260-10 MFN: 01 Responsible Party Cage: LO532 Name: GLAXO WELCOME INC. Address: FIVE MOORE DRIVE Box: 13438 City: RESEARCH TRIANGLE PARK NC 27709 Info Phone Number: 919-248-2100 Emergency Phone Number: 919-248-2700 Preparer's Name: UNKNOWN Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: 09979 Name: BURROUGHS WELLCOME CO Address: 3030 CORNWALLIS ROAD City: RESEARCH TRIANGLE PARK NC 27709 Phone: 919-248-3000 Cage: 5P291 Name: BURROUGHS WELLCOME CO NATIONAL ACCOUNTS DIV Address: 3030 CORNWALLIS RD City: RESEARCH TRIANGLE PARK NC 27709-4416 Phone: UNKNOWN Cage: 34006 Name: GLAXO WELLCOME INC. Address: 5 MOORE DR Box: 13398 City: DURHAM NC 27709 Phone: 919-248-2100 Cage: LO532 Name: GLAXO WELLCOME INC. Address: FIVE MOORE DRIVE Box: 13438 City: RESEARCH TRIANGLE PARK NC 27709 Phone: 919-248-2100 ======================================================= Item Description Information ======================================================= Item Manager: S9M Item Name: DIGOXIN INJECTION,USP Specification Number: NONE Type/Grade/Class: NONE Unit of Issue: PG UI Container Qty: 1 Type of Container: PACKAGE ======================================================= Ingredients ======================================================= Cas: 20830-75-5 RTECS #: IH6125000 Name: DIGOXIN (SARA 302) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 64-17-5 RTECS #: KQ6300000 Name: ETHYL ALCOHOL (ETHANOL) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: 1000 PPM ACGIH TLV: 1000 PPM; 9596 ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: LD50 (ORAL, CAT) IS 0.2 MG/KG. Route Of Entry Inds - Inhalation: YES Skin: NO Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: TARGET ORGANS:EYE, CNS, HEART, RESPIRATORY & GI TRACTS. ACUTE & CHRONIC- FOR THERAPEUTIC USE ONLY WHEN PRESCRIBED BY A PHYSICIAN. VERY TOXIC BY INHALATION/INGESTION IN EXCESS OF THERAPEUTIC DOSE. EYE CONTACT CAN CAUSE VISUAL DISTURBANCES. OVERDOSES MAY CAUSE LOW BLOOD PRESSURE & PAIN. MASSIVE OVERDOSE: HEART FAILURE. Explanation Of Carcinogenicity: NONE Signs And Symptions Of Overexposure: NAUSEA, VOMITING, CARDIAC IRREGULARITIES, DIARRHEA, ABDOMINAL PAIN, YELLOW VISION, LOW BLOOD PRESSURE, IRREGULAR PULSE Medical Cond Aggravated By Exposure: INDIVIDUALS WITH PRE-EXISTING DISEASES OF THE EYE, SKIN, RESPIRATORY TRACT, HEART, CNS MAY HAVE INCREASED SUSCEPTIBILITY TO THE TOXICITY OF EXCESSIVE EXPOSURES. First Aid: CALL PHYSICIAN IF SYMPTOMS PERSIST. EYE:IMMEDIATELY FLUSH WITH WATER FOR 15 MINUTES. HOLD EYELIDS OPEN. CALL PHYSICIAN. SKIN:WASH WITH SOAP & WATER. INHALED:REMOVE TO FRESH AIR. PROVIDE CPR/OXYGEN IF NEEDED. ORAL:IF CONSCIOUS, WASH OUT MOUTH. ADMINISTER CHARCOAL IF WITHIN 1 HOUR OF INGESTION. CALL A PHYSICIAN/POISON CONTROL CENTER IMMEDIATELY. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: WEAR PROTECTIVE EQUIPMENT. ABSORB SPILL WITH VERMICULITE OR OTHER INERT MATERIAL. PLACE IN A CONTAINER FOR CHEMICAL WASTE. CLEAN AREA WITH SOAP AND WATER. Neutralizing Agent: NOT RELEVANT Waste Disposal Methods: DISPOSE OF IN ACCORDANCE WITH ALL LOCAL, STATE AND FEDERAL REGULATIONS. Handling And Storage Precautions: STORE IN COOL, DRY PLACE. KEEP CONTAINER TIGHTLY CLOSED. KEEP OUT OF REACH OF CHILDREN. Other Precautions: VERY TOXIC. AS A GENERAL RULE, WHEN HANDLING PHARMACEUTICAL PRODUCTS, AVOID ALL FORMS OF CONTACT AND INHALATION OF DUST, FUMES, MISTS, AND/OR VAPORS ASSOCIATED WITH THE PRODUCT. WASH THOROUGHLY AFTER HANDLING AND BEFORE EATING OR DRINKING. ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Text: UNKNOWN Lower Limits: UNKNOWN Upper Limits: UNKNOWN Extinguishing Media: WATER SPRAY, CARBON DIOXIDE, FOAM OR DRY CHEMICAL. 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: TOXIC AND IRRITATING FUMES MAY BE FORMED. ======================================================= Control Measures ======================================================= Respiratory Protection: IF ENGINEERING CONTROLS DO NOT MAINTAIN AIRBORNE CONCENTRATIONS TO AN ACCEPTABLE LEVEL, A NIOSH-APPROVED RESPIRATOR MUST BE WORN. IN EMERGENCY, USE SELF-CONTAINED BREATHING APPARATUS. Ventilation: USE GENERAL OR LOCAL EXHAUST VENTILATION TO KEEP FUME OR DUST LEVELS AS LOW AS POSSIBLE. Protective Gloves: LATEX Eye Protection: SAFETY GLASSES/CHEMICAL SPLASH GOGGLES Other Protective Equipment: SAFETY SHOWER AND EYE WASH FOUNTAIN SHOULD BE LOCATED NEARBY. WEAR APPROPRIATE PROTECTIVE CLOTHING FOR RISK OF EXPOSURE. Work Hygienic Practices: OBSERVE GOOD PERSONAL HYGIENE PRACTICES AND RECOMMENDED PROCEDURES. DO NOT WEAR CONTAMINATED CLOTHING. ======================================================= Physical/Chemical Properties ======================================================= HCC: T2 NRC/State LIC No: NOT RELEVANT M.P/F.P Text: 509F,265C Decomp Text: UNKNOWN Spec Gravity: UNKNOWN Viscosity: UNKNOWN Evaporation Rate & Reference: NOT RELEVANT Solubility in Water: INSOLUBLE Appearance and Odor: DIGOXIN IS COLORLESS, ODORLESS CRYSTALS/WHITE/ALMOST WHITE CRYSTALLINE POWDER Corrosion Rate: UNKNOWN ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: EXCESSIVE HEAT Materials To Avoid: UNKNOWN Hazardous Decomposition Products: UNKNOWN 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: LO532 Trans ID NO: 75547 Product ID: LANOXIN ELIXIR AND INJECTION,NDC 00081-0260-10 MSDS Prepared Date: 10/31/1994 Review Date: 12/03/1999 MFN: 1 Tech Entry NOS Shipping Nm: CONTAINS DIGOXIN AND ETHANOL. Radioactivity: NOT RELEVANT Net Unit Weight: 0.22 LB DOD Exemption NUM: NOT RELEVANT Multiple KIT Number: 0 Review IND: Y Unit Of Issue: PG Container QTY: 1 Type Of Container: PACKAGE ======================================================= Detail DOT Information ======================================================= DOT PSN Code: QKM Symbols: G DOT Proper Shipping Name: TOXIC LIQUIDS, ORGANIC, N.O.S. Hazard Class: 6.1 UN ID Num: UN2810 DOT Packaging Group: I Label: POISON Special Provision: T42 Packaging Exception: NONE Non Bulk Pack: 201 Bulk Pack: 243 Max Qty Pass: 1 L Max Qty Cargo: 30 L Vessel Stow Req: B Water/Ship/Other Req: 40 ======================================================= Detail IMO Information ======================================================= IMO PSN Code: OTX IMO Proper Shipping Name: TOXIC LIQUID, ORGANIC, N.O.S. o IMDG Page Number: 6270-1 UN Number: 2810 UN Hazard Class: 6.1 IMO Packaging Group: I/II/III Subsidiary Risk Label: - EMS Number: 6.1-02 MED First Aid Guide NUM: T ======================================================= Detail IATA Information ======================================================= IATA PSN Code: YID IATA UN ID Num: 2810 IATA Proper Shipping Name: TOXIC LIQUID, ORGANIC, N.O.S. * IATA UN Class: 6.1 IATA Label: TOXIC UN Packing Group: I Packing Note Passenger: 603 Max Quant Pass: 1L Max Quant Cargo: 30L Packaging Note Cargo: 604 Exceptions: A3 ======================================================= Detail AFI Information ======================================================= AFI PSN Code: YGE AFI Symbols: * AFI Proper Shipping Name: TOXIC LIQUID, ORGANIC, N.O.S. AFI Hazard Class: 6.1 AFI UN ID NUM: UN2810 AFI Packing Group: I Special Provisions: P3 Back Pack Reference: A10.5 ======================================================= HAZCOM Label ======================================================= Product ID: LANOXIN ELIXIR AND INJECTION,NDC 00081-0260-10 Cage: LO532 Assigned IND: Y Company Name: GLAXO WELLCOME INC. Street: FIVE MOORE DRIVE PO Box: 13438 City: RESEARCH TRIANGLE PARK NC Zipcode: 27709 Health Emergency Phone: 919-248-2700 Date Of Label Review: 06/11/1996 Status Code: C Label Date: 06/11/1996 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.