SAFETY DATA SHEET - MEDISCA

1 SAFETY data SHEETSECTION 1: PRODUCT IDENTIFICATIONDICLOFENAC SODIUM, USPPRODUCT NAME2683 PRODUCT CODEMEDISCA : | Fax.: Route 3, Unit C, Plattsburgh, NY, 129013955 W. Mesa Vista Ave., Unit A-10, Las Vegas, NV, 891186641 N. Belt Line Road, Suite 130, Irving, TX, 75063 MEDISCA Pharmaceutique : | Fax.: Rue Dobrin, St. Laurent, QC, H4R 2L821300 Gordon Way, Unit 153/158, Richmond, BC V6W 1M2 MEDISCA Australia PTY LTDTel.: | Fax.: 7, Heritage Business Park5-9 Ricketty Street, Mascot, NSW 2020 CHEMTREC Day or Night Within USA and Canada: 1-800-424-9300 NSW Poisons Information Centre: 131 126 EMERGENCY PHONEA nalgesic; Anti-inflammatory; Antipyretic (NSAID)USESSECTION 2: HAZARDS IDENTIFICATIONA cute Toxicity - Oral (Category 3)Acute Toxicity - Dermal (Category 4)Skin Irritation (Category 2)Eye Irritation (Category 2A)Toxic to Reproduction (Category 2)Specific Target Organ Toxicity - Repeated Exposure (Category 1) - (cardiovascular system, gastrointestinal tract, liver)Acute Aquatic Toxicity (Category 3)GHS CLASSIFICATIONPICTOGRAMD angerSIGNAL WORDT oxic if swallowed.

2 Harmful in contact with skin. Causes skin and serious eye irritation. Suspected of damaging fertility or the unborn child. Causes damage to organs (cardiovascular system, gastrointestinal tract, liver, renal system) through prolonged or repeated exposure. Harmful to aquatic STATEMENT(S) Repeated exposure may cause skin dryness or HAZARDSWash thoroughly after handling. Do not eat, drink or smoke when using this special instructions before use. Do not handle until all SAFETY precautions have been read and understood. Wear protective gloves, protective clothing, eye protection, face not breathe dust/fume/gas/mist/ release to the STATEMENT(S)PreventionDICLOFENAC SODIUM, USPPage 1 of 8 Last Revision: 07/2018 SAFETY data SHEETIF SWALLOWED: Immediately call a poison center or medical professional; Rinse ON SKIN (HAIR): Wash with plenty of water.

3 Call a poison center or medical professional. Take off immediately all contaminated clothing and wash it before IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical EXPOSED OR CONCERNED: Get medical medical advice/attention if you feel locked of contents and/or container in accordance with local 3 0 HMIS CLASSIFICATIONH ealth HazardFlammability 0 GReactivityPersonal ProtectionSECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS2-[(2,6-dichlorophenyl)amino] -, monosodium saltCHEMICAL NAMENot applicableBOTANICAL NAMENot applicableSYNONYMC H Cl NNaO CHEMICAL FORMULA15307-79-6 CAS NUMBERNot applicableALTERNATE CAS NUMBERMOLECULAR BY WEIGHTCAS NUMBERCHEMICAL NAME10015307-79-6 DICLOFENAC SODIUMCOMPOSITIONT here are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as health hazards and hence require reporting in this family.

4 Phenylacetic acid 4: FIRST-AID MEASURESF lush with copious amounts of water for 15 minutes, separating eyelids with fingers. If irritation persists seek medical CASE OF EYE CONTACTWash with soap & water for 15 minutes. If irritation persists seek medical CASE OF SKIN CONTACTCall a physician. Wash out mouth with water. Do not induce vomiting without medical SWALLOWEDR emove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physicianIF INHALEDNot expected to present a significant hazard under anticipated conditions of normal AND EFFECTSSECTION 5: FIREFIGHTING MEASURESNo unusual fire or explosion hazards explosion properties:Minimum ignition energy (MIE) - dust cloud: > 1000 mJSPECIFIC HAZARDS ARISING FROM THE CHEMICALMay be combustible at high temperatureFLAMMABLE PROPERTIESDICLOFENAC SODIUM, USPPage 2 of 8 Last Revision: 07/2018 SAFETY data SHEETU nder fire conditions, hazardous fumes will be COMBUSTION PRODUCTSS mall fire: dry chemical, CO or water spray.

5 Large fire: dry chemical, CO , alcohol resistant foam or water spray. Do not get water inside MEDIAWear self-contained breathing apparatus and protective clothing to prevent contact with skin and EQUIPMENT AND PRECAUTIONS FOR FIREFIGHTERSSECTION 6: ACCIDENTAL RELEASE MEASURESWear respiratory protection. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing PRECAUTIONSOn land, sweep or shovel into suitable containers. Minimize generation of & MATERIAL FOR CONTAINMENTDo not touch damaged containers or spilled material unless wearing appropriate protective clothing. Wear respirator, chemical SAFETY goggles, rubber boots and heavy rubber gloves. Stop leak if you can do it without risk. Prevent entry into waterways, sewers, basements or confined areas.

6 Shut off all sources of ignition. Evacuate the area. If necessary, employ water fog to disperse the vapors. Absorb the matter with compatible vermiculite or other absorbing material. Place in a suitable container and retain for disposal. Ventilate and clean the affected area. Do not flush into sewerage system or to PROCEDURESECTION 7: HANDLING AND STORAGEDo not inhale. Avoid contact with eyes, skin and clothing. Avoid prolonged or repeated exposure. Wash thoroughly after handling. Store away from incompatible materials, in a well-ventilated area. Eliminate all sources of ignition. Store in accordance with local regulations. Do not store in unlabelled containers. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Use appropriate containment to avoid environmental FOR SAFE HANDLINGS tore in original container, tightly sealed, protected from direct sunlight and moisture.

7 Preserve in tight, light-resistant containers. Keep in dry CONDITIONSSECTION 8: EXPOSURE CONTROLS/ PERSONAL PROTECTIONC hemical Name: DICLOFENAC SODIUM CAS #: 15307-79-6 IDLHRELSTELC eilingTWAR emarksAIHA WEELN/LN/LN/L---Safe Work Australia HSISN/LN/LN/L---HSEN/LN/LN/L---OSHA PELN/LN/L----ACGIH TLVN/LN/LN/L---NIOSHN/LN/LN/LN/LN/L-N/L = Not ListedConsult local authorities for provincial or state exposure limits. Particulates not otherwise regulated, respirable fraction: 5 mg/m .EXPOSURE GUIDELINESDICLOFENAC SODIUM, USPPage 3 of 8 Last Revision: 07/2018 SAFETY data SHEETEyes: Wear appropriate protective eyeglasses or chemical SAFETY goggles as described by WHMIS or OSHA's eye and face protection regulations in 29 CFR or European Standard EN166. Skin: Wear appropriate gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to minimize contact with skin.

8 Respirators: Follow WHMIS or OSHA respirator regulations found in 29 CFR or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are PROTECTIVE EQUIPMENTA dequate mechanical ventilation. Fumehood, eye wash station, and SAFETY ENGINEERING CONTROLSUSP: ELV: Industrial Use: TWA: mg/m NOTESSECTION 9: PHYSICAL AND CHEMICAL PROPERTIESS olidPHYSICAL STATEW hite to off-white, hygroscopic, crystalline soluble in methanol; soluble in ethanol; sparingly soluble in water; practically insoluble in chloroform and in be combustible at high - (1%)(283 - 285) C, ( ) FNot availableODOR THRESHOLDpHMELTING POINTNot availableNot available(283 - 285) C, ( ) FBOILING POINTFREEZING POINTFLASH - availableNot availableEVAPORATION RATEEXPLOSIVE LIMITSPECIFIC GRAVITYNot availableNot available< kPa (25 C)UPPER FLAMMABLE/ EXPLOSIVE LIMIT(S)LOWER FLAMMABLE/ EXPLOSIVE LIMIT(S)VAPOR PRESSURENot availableNot DENSITY (AIR = 1)RELATIVE DENSITY (WATER = 1)log P (OCTANOL-WATER)Not availableNot availableNot availableDECOMPOSITION TEMPERATUREVISCOSITYAUTO-IGNITION TEMPERATUREThe physical data presented above are typical values and should not be construed as a 10.

9 STABILITY AND REACTIVITYNot establishedREACTIVITYS table under recommended storage conditionsSTABILITYS trong oxidants, strong bases and acid chlorine TO AVOIDT oxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides and other gases may occurHAZARDOUS DECOMPOSITION PRODUCTSWill not occurHAZARDOUS POLYMERIZATIONNot establishedPOSSIBLITY OF HAZARDOUS REACTIONDICLOFENAC SODIUM, USPPage 4 of 8 Last Revision: 07/2018 SAFETY data SHEETM oisture, sunlight and extreme temperaturesCONDITIONS TO AVOIDSECTION 11: TOXICOLOGICAL INFORMATIONOral: Rat: LD50: (mg/kg): 53 Dermal: Rabbit LD50: (mg/kg): 2000 Inhalation: Rat: LC50: (mg/L/4hr): Not availableACUTE TOXICITYC auses skin skin reactions such as rash or pruritus may occur in patients given diclofenac. More serious skin reactions attributed to diclofenac include bullous dermatitis and erythema CORROSION/IRRITATIONC auses serious eye diclofenac and related drugs have been implicated in reports of corneal toxicity.

10 Ulceration of the conjunctiva or cornea, corneal or scleral melts, and perforations have been reported in patients using diclofenac eye drops, particularly after cataract surgery. Keratitis and perforations were also reported with ketorolac eye drops, although less EYE DAMAGE/EYE IRRITATIONR espiratory sensitization: Due to lack of data the classification is not sensitization: Due to lack of data the classification is not formulation containing this material showed no evidence of skin sensitization when tested in have been reports of allergic reactions and contact dermatitis following therapeutic exposure to this OR SKIN SENSITIZATIONB ased on available data , the classification criteria are not CELL MUTAGENICITYDICLOFENAC SODIUM is not SODIUM is not SODIUM is not product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive Proposition 65 ADDITIONAL CARCINOGENICITY INFORMATIONB ased on available data , the classification criteria are not of damaging fertility or the unborn use of nonsteroidal anti-inflammatory agents (NSAIDs)