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Lidocaine Hydrochloride, USP Lidocaine Hydrochloride, USP SDS Preparation Date (05/01/2017): Page 1 of 13 SAFETY DATA SHEET Section 1 Identification of the substance/mixture and of the company/undertaking Product Identifier Identification on the label/ Tradename: Lidocaine Hydrochloride, USP Identification of the Product: CAS# 6108-05-0 RTECS No.: AN770000 CI No.: Not Available Relevant identified uses of the substance and uses advised against: Identified Uses: Topical anesthetic Uses Advised Against: No information available Name, address, and telephone number of the manufacturer: Refer to Supplier Name, address, and telephone number of the supplier: Encore Scientific 801 W New Orleans Street Broken Arrow, OK, USA 74011 Supplier's Telephone # 800-454-2304 Monday to Friday 8:00 am to 6:00 pm (Central time) 24 Hr. Emergency Tel # INFOTRAC: (800) 535-5053 (Within Continental US and Canada); (352)323-3500 (International) Section 2 Hazards Identification Classification This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Acute toxicity – Oral Category 4 Label elements Warning Hazard statements Harmful if swallowed

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Page 1: Lidocaine Hydrochloride, USP - Encore ScientificLidocaine Hydrochloride, USP SDS Preparation Date (05/01/2017): Page 1 of 13 SAFETY DATA SHEET Section 1 Identification of the substance/mixture

Lidocaine Hydrochloride, USP Lidocaine Hydrochloride, USP

SDS Preparation Date (05/01/2017): Page 1 of 13

SAFETY DATA SHEET

Section 1 Identification of the substance/mixture and of the company/undertaking

Product Identifier Identification on the label/ Tradename: Lidocaine Hydrochloride, USP Identification of the Product: CAS# 6108-05-0 RTECS No.: AN770000 CI No.: Not Available

Relevant identified uses of the substance and uses advised against: Identified Uses: Topical anesthetic Uses Advised Against: No information available Name, address, and telephone number of the manufacturer: Refer to Supplier Name, address, and telephone number of the supplier: Encore Scientific 801 W New Orleans Street Broken Arrow, OK, USA 74011 Supplier's Telephone # 800-454-2304 Monday to Friday 8:00 am to 6:00 pm (Central time) 24 Hr. Emergency Tel # INFOTRAC: (800) 535-5053 (Within Continental US and Canada); (352)323-3500 (International)

Section 2 Hazards Identification

Classification This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Acute toxicity – Oral Category 4

Label elements Warning Hazard statements Harmful if swallowed

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Section 2 Hazards Identification (continued)

Hazards not otherwise classified (HNOC) Not Applicable Other hazards Not available Precautionary Statements – Prevention Wash face, hands and any exposed skin thoroughly after handling Do not eat, drink or smoke when using this product IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell Rinse mouth Precautionary Statements – Disposal Dispose of contents/container to an approved waste disposal plant

Section 3 Composition/information on ingredients

Components CAS No. Weight %

Lidocaine Hydrochloride 6108-05-0 100

Section 4 First aid measures

General Advice: Poison information centers in each State capital city can provide additional assistance for scheduled poisons (13

1126) Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Eye Contact: Flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs. Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get

medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an

unconscious person. Obtain medical attention.

Most important symptoms and effects, both acute and delayed Symptoms May cause eye/skin irritation. Numbness of skin/eyes at site of contact. May cause nausea and vomiting. May

cause abdominal discomfort. May cause numbness of the upper respiratory tract if inhaled. May cause numbness of the digestive tract if swallowed. Central nervous system effects. May affect the cardiovascular system.

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Section 4 First aid measures (continued)

Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically Protection of first-aiders First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of

contaminated clothing and equipment as bio-hazardous waste

Section 5 Fire-Fighting measures

Extinguishing Media Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Unsuitable Extinguishing Media: No information available.

Specific hazards arising from the chemical Hazardous Combustion Products: Carbon oxides. Nitrogen oxides, halogenated compounds (hydrogen chloride gas) Specific hazards: May be combustible at high temperatures

Special Protective Actions for Firefighters Specific Methods: No information available. Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand,

MSHA/NIOSH (approved or equivalent)and full protective gear

Section 6 Accidental release measures

Personal precautions, protective equipment and emergency procedures Personal Precautions: Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Do not touch

damaged containers or spilled material unless wearing appropriate protective clothing. Use personal protective equipment. Avoid contact with skin, eyes and clothing. Avoid breathing dust. Avoid dust formation. Remove all sources of ignition. All equipment used when handling the product must be grounded.

Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Prevent

entry into waterways, sewers, basements or confined areas.

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Section 6 Accidental release measures (continued)

Methods and material for containment and cleaning up Methods for containment Cover with plastic sheet to prevent spreading. Prevent dust cloud. Methods for cleaning up Sweep up and shovel into suitable containers for disposal. Avoid creating dust. Clean

contaminated surface thorough

Section 7 Handling and storage

Precautions for safe handling

Technical Measures/Precautions: Provide sufficient air exchange and/or exhaust in work rooms. All equipment used when handling the product must be grounded. Avoid dust formation. Remove all sources of ignition. Keep away from incompatible materials.

Safe Handling Advice: Wear personal protective equipment. Use only in well-ventilated areas. Avoid contact with skin, eyes and clothing. Keep away from heat and sources of ignition. Avoid dust formation. Do not smoke. Do not ingest. Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities Technical Measures/Storage Conditions: Keep containers tightly closed in a dry, cool and well-ventilated place. Store at room temperature in the original container. Keep away from heat and sources of ignition. Store in a segregated and approved area. Store away from incompatible materials. Incompatible Materials: Strong oxidizing agent

Section 8 Exposure Controls/Personal Protection

Control parameters United States

Components OSHA NIOSH ACGIH AIHA WHEEL

Lidocaine Hydrochloride

None None None None

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Section 8 Exposure Controls/Personal Protection (continued)

Canada

Components Alberta British Columbia Ontario Quebec

Lidocaine Hydrochloride

None None None None

Australia and Mexico

Components Australia Mexico

Lidocaine Hydrochloride None None

Appropriate engineering controls Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels

below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

Individual protection measures, such as personal protective equipment Personal Protection Equipment:

Eye protection: Goggles. Safety glasses with side-shields. Skin and body protection: Long sleeved clothing. Gloves. Respiratory protection: Wear respirator with dust filter. Be sure to use an approved/certified respirator or

equivalent. Hygiene measures: Avoid contact with skin, eyes and clothing. When using, do not eat, drink or smoke.

Wash hands before breaks and immediately after handling the product.

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Section 9 Physical and chemical properties

Information on basic physical and chemical properties:

Physical state: Solid. (Powdered solid. Crystalline powder. Crystalline solid.)

Odor: Characteristic

Taste: Not available

Color: White

Molecular Weight: 288.81g/mole

pH: Not available

Boiling Point: Not available

Melting Point: 74°C/ 165.2°

Formula: C14H22N2O-HCl-H2

Flash Point (°C): Not available

Flashpoint (°C/°F): Not available

Flash Point Tested according to: Not available

Lower Explosion Limit (%): Not available

Upper Explosion Limit (%): Not available

Autoignition Temperature (°C/°F): Not available

Decomposition temperature(°C/°F): No information available

Critical Temperature: Not available

Specific Gravity: Not available

Vapor Pressure@ 20°C (kPa): Not available

Vapor Density: Not available

Density (g/cm3): Not available

Evaporation rate: Not available

VOC content (g/L): Not available

Viscosity: No information available

Miscibility: Not available

Odor Threshold (ppm): Not available

Partition coefficient(n-octanol/water): Not available

Ionicity (in water): Not available

Dispersion Properties: Not available

Solubility: Easily soluble in water Insoluble in diethyl ether Soluble in Benzene Soluble in Ethanol Soluble in Chloroform

Section 10 Stability and reactivity

Reactivity Reactive with oxidizing agents Chemical stability Stability: Stable under recommended storage conditions. Possibility of Hazardous Reactions: Hazardous polymerization does not occur Conditions to avoid: Heat. Incompatible materials. Incompatible Materials: Strong oxidizing agents. Hazardous decomposition products: Carbon monoxide. Carbon dioxide. Nitrogen oxides (NOx). Hydrogen chloride gas Other Information Corrosivity: No information available Special Remarks on Corrosivity: No information available

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Section 11 Toxicological information

Information on likely routes of exposure Principal Routes of Exposure: Skin. Ingestion. Inhalation. Acute toxicity: Component Information Lidocaine Hydrochloride – 6108-05-0 LD50/oral/rat = No information available LD50/oral/mouse = 292mg/k Oral LD50 Mouse LD50/dermal/rat = No information available LD50/dermal/rabbit = No information available LC50/inhalation/rat = No information available LC50/inhalation/mouse = No information available Other LD50 or LC50 information = No information available Product Information: LD50/oral/rat = VALUE- Acute Tox Oral = No information available LD50/oral/mouse = Value - Acute Tox Oral = 292mg/kg LD50/dermal/rabbit VALUE-Acute Tox Dermal = No information available LD50/dermal/rat VALUE -Acute Tox Dermal = No information available LC50/inhalation/rat VALUE-Vapor = No information available VALUE-Gas = No information available VALUE-Dust/Mist = No information available LC50/Inhalation/mouse VALUE-Vapor = No information available VALUE - Gas = No information available VALUE - Dust/Mist = No information available

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Section 11 Toxicological information (continued)

Symptoms Skin Contact: May cause skin irritation and numbness (anesthetic effect). When applied to the skin, it produces an anesthetic

effect by blocking the signals at the nerve endings of the skin. when compounded with an ointment and applied topically, It may be absorbed by the skin cause systemic effects similar to that of ingestion

Eye Contact: May cause eye irritation. May cause numbness. Inhalation: May cause respiratory tract irritation. May cause numbness of the upper respiratory tract. Ingestion: Harmful if swallowed. May cause abdominal discomfort. Ingestion may cause nausea, vomiting. May affect

behavior/central nervous system (convulsions/seizures, drowsiness, lightheadedness, dizziness, confusion, disorientation, muscle twitching or trembling, somnolence, unusual excitement, unusual tiredness or weakness, nervousness, restlessness), cardiovascular system (hypotension, change in heartrate with possible cardiac arrest). May also cause shortness of breath or trouble breathing, ringing or buzzing in the ears, feeling hot, cold or numb, increased sweating, blurred or double vision.

Aspiration hazard: No information available Delayed and immediate effects as well as chronic effects from short and long-term exposure Chronic Toxicity: Prolonged or repeated skin contact may cause allergic skin reaction with rash, hives, swelling, or abnormal

sensation at the site of application. Ingestion/Inhalation: It is rare, but it may cause allergic reaction with cough, difficulty swallowing or tongue swelling, dizziness or fainting, hives or swelling of the eyelids, face or lips; itching or skin rash, stuffy nose, chest tightness, shortness of breath, trouble breathing or wheezing. Medical Conditions Aggravated by Exposure: Hypersensitivity to material; respiratory depression; existing cardiac conditions; broken or inflamed skin, burns, or open wounds at the place of application. More can be absorbed into the body quickly, which increases the chance of side effects; Liver disease (severe). The risk of side effects may be increased because of the slower removal of lidocaine from the body.

Sensitization: No information available Mutagenic Effects: No information available Carcinogenic effects:Not considered carcinogenic

Components ACGIH-

Carcinogens IARC NTP OSHA HCS –

Carcinogens Australia – Prohibited

Carcinogenic Substances

Australia – Notifiable Carcinogenic Substances

Lidocaine Hydrochloride

Not listed Not listed Not listed Not listed Not listed Not listed

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Section 11 Toxicological information (continued)

Reproductive toxicity No data is available Reproductive Effects: No information available Developmental Effects: No information available Teratogenic Effects: No information available Specific Target Organ Toxicity STOT - single exposure No information available STOT - repeated exposure No information available Target Organs: No information available

Section 12 Ecological information

Ecotoxicity Ecotoxicity effects: No data available. Persistence and degradability: No information available Bioaccumulative potential: No information available Mobility: No information available

Section 13 Disposal considerations

Disposal Methods Waste from residues / unused products: Waste must be disposed of in accordance with Federal, State and Local regulation. Contaminated packaging: Empty containers should be taken for local recycling, recovery or waste disposal.

Components RCRA – F Series Wastes

RCRA – K Series Wastes

RCRA – P Series Wastes

RCRA – U Series Wastes

Lidocaine Hydrochloride None None None None

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Section 14 Transport information

DOT UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: None ERG No: No information available Marine Pollutant: No data available DOT RQ (lbs): No information available TDG (Canada) UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available ADR UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Packing Group: No information available Subsidiary Risk: No information available Classification Code: No information available Description: No information available CEFIC Tremcard No: No information available IMO / IMDG UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available

Subsidiary Risk: No information available Packing Group: No information available Description: No information available IMDG Page: No information available Marine Pollutant: No information available MFAG: No information available Maximum Quantity: No information available RID UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Classification Code: No information available Description: No information available ICAO UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available IATA UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available

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Section 15 Regulation information

International Inventories

Components U.S. TSCA KOREA KECL

Philippines (PICCS)

Japan ENCS

China Australia (AICS)

EINECS-No.

Lidocaine Hydrochloride

Not Present Exempt from TSCA 8(b) Inventory listing since it is a hydrate. However, the anhydrous form (CAS no. 73-78-9) is listed on the TSCA 8(b) Inventory.

Not present Not present Not present Not present Present Not present

U.S. Regulations California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986. Chemicals Known to the State of California to Cause Cancer: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below) Chemicals Known to the State of California to Cause Reproductive Toxicity: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)

Components Carcinogen Developmental Toxicity Male Reproductive Toxicity

Female Reproductive Toxicity

Lidocaine HCL Not listed Not listed Not listed Not listed

CERCLA/SARA

Components CERCLA-Hazadous substances and their

Reportable Quantities

Section 302 Extremely Hazardous Substances and

TPQs

Section 302 Extremely Hazardous Substances

and RQs

Section 313 -Chemical Category

Section 313 - Reporting de minimis

Lidocaine HCL None None None None None

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Section 15 Regulation information (continued)

U.S. TSCA

Components TSCA Section 5(a)2 - Chemicals With Significant New Use Rules (SNURS)

TSCA 8(d) -Health and Safety Reporting

Lidocaine HCL Not applicable Not applicable

Canada WHMIS hazard class: D1B Toxic Materials Canada Controlled Products Regulation: This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS contains all of the information required by the CPR. Inventory

Components Canada (DSL) Canada (NDSL)

Lidocaine HCL Not listed Not listed

Components CEPA Schedule I – Toxic Substances

CEPA – 2010 Greenhouse Gases Subject to Mandatory Reporting

Lidocaine HCL Not listed Not listed EU Classification R-phrase(s) R22 - Harmful if swallowed. S -phrase(s) S46 - If swallowed, seek medical advice immediately and show this container or label. S36 - Wear suitable protective clothing

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Section 15 Regulation information (continued)

Components Classification Concentration Limits Safety Phrases Lidocaine HCL No information

The product is classified in accordance with Annex VI to Directive 67/548/EEC Indication of danger: Xn – Harmful

Section 16 Other information

Further information: This information is based upon the present state of our knowledge. This SDS has been compiled and is

solely intended for this product. Notice to reader: Employers should use this information only as a supplement to other information gathered by them, and should make independent judgment of suitability of this information to ensure proper use and protect the health and safety of employees. This information is furnished without warranty, and any use of the product not in conformance with this Safety Data Sheet, or in combination with any other product or process, is the responsibility of the user.