Lidocaine Hydrochloride Injection

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

This product is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200).

2.2 Label elements

Emergency Overview This product is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200). Appearance Dark brown Physical State Viscous liquid Odor Faint, characteristic

Prevention

None

Response

None

Storage

None Do not store at temperatures above 40°C. Keep tightly closed in a dry and cool place. Keep in properly labeled containers. Incompatible Products Strong alkalis. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Control parameters Exposure Guidelines Chemical Name ACGIH TLV OSHA PEL NIOSH IDLH TWA: 0.01 ppm Iodine (Inhalable fraction and vapor) TWA-Ceiling: 0.1 ppm IDLH: 2 ppm 7553-56-2 STEL: 0.1ppm TWA-Ceiling: 0.1 ppm (Aerosol and vapor) ACGIH TLV American Conference of Governmental Industrial Hygienists - Threshold Limit Value OSHA PEL Occupational Safety and Health Administration - Permissible Exposure Limits NIOSH IDLH Immediately Dangerous to Life or Health Appropriate engineering controls Engineering Measures Showers Eyewash stations Ventilation systems Individual protection measures, such as personal protective equipment Eye/Face Protection No special protection required. Skin and Body Protection No special protection required. Page 4 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: Respiratory Protection If exposure limits are exceeded or irritation is experienced, NIOSH/MSHA approved respiratory protection should be worn. Positive-pressure supplied air respirators may be required for high airborne contaminant concentrations. Respiratory protection must be provided in accordance with current local regulations. Hygiene Measures Handle in accordance with good industrial hygiene and safety practice. 9. PHYSICAL AND CHEMICAL PROPERTIES Physical and Chemical Properties Physical State Viscous liquid

Precautionary statements

Disposal None

2.3 Other hazards

Not applicable Unknown Toxicity 11% of the mixture consists of ingredient(s) of unknown toxicity

Further information

Harmful to aquatic life with long lasting effects. Softening Point No data available VOC Content (%) No data available Particle Size No data available Particle Size Distribution No data available Page 5 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: 10. STABILITY AND REACTIVITY Reactivity Incompatible with strong alkalis. Chemical stability Stable under recommended storage conditions. Harsh iodine fumes may be emitted if product is heated to temperatures greater than 80°C. Possibility of Hazardous Reactions None under normal processing. Hazardous Polymerization Hazardous polymerization does not occur. Conditions to avoid None known based on information supplied. Incompatible materials Strong alkalis. Hazardous Decomposition Products Carbon oxides. NFPA

Interactions with other chemicals

Incompatible with strong alkalis. 3. COMPOSITION/INFORMATION ON INGREDIENTS Chemical Name CAS No Weight-% Trade Secret Povidone-iodine 25655-41-8 8 - 12 * Page 2 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: 4. FIRST AID MEASURES First aid measures General Advice Show this safety data sheet to the doctor in attendance. Eye Contact Rinse thoroughly with plenty of water, also under the eyelids. If eye irritation persists: Get medical advice/attention. Skin Contact Wash skin with soap and water. Inhalation Remove to fresh air. If symptoms persist, call a doctor. Ingestion Rinse mouth immediately and drink plenty of water. Never give anything by mouth to an unconscious person. Do NOT induce vomiting. Call a physician. Most important symptoms and effects, both acute and delayed Most Important Symptoms and May cause slight eye irritation. Effects Indication of any immediate medical attention and special treatment needed Notes to Doctor Treat symptomatically. 5. FIRE-FIGHTING MEASURES Suitable Extinguishing Media Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. Unsuitable extinguishing media CAUTION: Use of water spray when fighting fire may be inefficient. Specific Hazards Arising from the Chemical Harsh iodine fumes may be emitted if product is heated to temperatures greater than 80°C. Hazardous Combustion Products Carbon oxides. Explosion Data Sensitivity to Mechanical Impact No. Sensitivity to Static Discharge No. Protective equipment and precautions for firefighters As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear. Page 3 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Personal Precautions Avoid contact with eyes. Environmental Precautions See Section 12 for additional Ecological Information. Methods and material for containment and cleaning up Methods for Containment Prevent further leakage or spillage if safe to do so. Methods for cleaning up Soak up with inert absorbent material. Keep in suitable, closed containers for disposal. 7. HANDLING AND STORAGE Precautions for safe handling Handling Avoid contact with eyes. Handle in accordance with good industrial hygiene and safety practice. Conditions for safe storage, including any incompatibilities

Appearance/Odor

Opaque Faint, characteristic Color Dark brown Odor Threshold No information available Property Values

Remarks

Method pH No data available None known Melting / freezing point No data available None known Boiling point / boiling range No data available None known Flash Point No data available None known Evaporation Rate No data available None known Flammability (solid, gas) No data available None known Flammability Limit in Air Upper flammability limit No data available None known Lower flammability limit No data available None known Vapor pressure No data available None known Vapor density No data available None known Specific Gravity ~1.04 None known Water Solubility Soluble None known Solubility in other solvents No data available None known Partition coefficient: n-octanol/water No data available None known Autoignition temperature No data available None known Decomposition temperature No data available None known Kinematic viscosity No data available None known Dynamic viscosity No data available None known Explosive properties No data available Oxidizing Properties No data available

TOXICOLOGICAL INFORMATION

Information on likely routes of exposure Product Information Product does not present an acute toxicity hazard based on known or supplied information. Inhalation Specific test data for the substance or mixture is not available. Eye Contact Specific test data for the substance or mixture is not available. Skin Contact Specific test data for the substance or mixture is not available. Ingestion Specific test data for the substance or mixture is not available. Component Information No information available. Information on toxicological effects Symptoms May cause redness and tearing of the eyes. Delayed and immediate effects as well as chronic effects from short and long-term exposure Sensitization No information available. Mutagenic Effects No information available. Carcinogenicity Contains no ingredients listed as a carcinogen. Reproductive Toxicity No information available. STOT - single exposure No information available. STOT - repeated exposure No information available. Page 6 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: Chronic Toxicity Carcinogenic potential is unknown. Target Organ Effects None known.

Aspiration hazard

No information available. Numerical measures of toxicity Product Information The following values are calculated based on chapter 3.1 of the GHS document Not applicable

ECOLOGICAL INFORMATION

Ecotoxicity Harmful to aquatic life with long lasting effects. Persistence and Degradability No information available. Bioaccumulation No information available.

Other hazards

No information available. 13. DISPOSAL CONSIDERATIONS Disposal methods Dispose of in accordance with all applicable federal, state, and local regulations. Contaminated Packaging Dispose of in accordance with all applicable federal, state, and local regulations. 14. TRANSPORT INFORMATION DOT Not regulated TDG Not regulated ICAO Not regulated IATA Not regulated IMDG/IMO Not regulated Page 7 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date: 15. REGULATORY INFORMATION Chemical Inventories TSCA Complies. DSL All components are listed either on the DSL or NDSL. TSCA - United States Toxic Substances Control Act Section 8(b) Inventory DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List US Federal Regulations SARA 313 Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals that are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372 SARA 311/312 Hazard Categories

Acute Health Hazards

No

Health hazards

No Fire Hazard No Sudden release of pressure hazard No Reactive Hazard No CWA (Clean Water Act) This product does not contain any substances that are regulated pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40 CFR 122.42) CERCLA This material, as supplied, does not contain any substances that are regulated as a hazardous substance under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302) or the Superfund Amendments and Reauthorization Act (SARA) (40 CFR 355). There may be specific reporting requirements at the local, regional, or state level pertaining to releases of this material. US State Regulations California Proposition 65 This product does not contain any Proposition 65 chemicals. U.S. State Right-to-Know Regulations Chemical Name New Jersey Massachusetts Pennsylvania Rhode Island Illinois Disodium phosphate X 7558-79-4 Sodium hydroxide X 1310-73-2 International Regulations Canada 1 Flammability 0 Instability 0 1 Flammability 0 Physical Hazard 0 Personal Protection - Prepared By Product Stewardship 23 British American Blvd. Latham, NY 12110 1-800-572-6501 Revision Date: New Revision Note New Reference INT0028/D001 Disclaimer The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text End of Safety Data Sheet

WHMIS Classification

Not controlled. Page 8 / 9 Aplicare® Povidone-Iodine Solution (10%, For Procedural Kit Usage) Revision Date:

Other physicochemical hazards

HMIS