Safety Data Sheet Lidocaine Ointment 5%, USP SDS DATE: 9/22/11 SECTION 1: PRODUCT AND COMPANY IDENTIFICATION Product Name: Lidocaine Ointment 5%, USP NDC #: Tube 57539-0221-5 Chemical Name (for active ingredient): 2-(Diethylamino)-N-(2,6-dimethylphenyl)-acetamide Chemical Family (for active ingredient): Acetamide Formula (for active ingredient): C14H22N2O Product Use: Pharmaceutical for Human Use Manufacturer: Novocol Inc. Address: 416 S. Taylor Ave. Louisville, CO USA 80027 Telephone: (800) 383-5158
Unlikely due to form of product. May cause irritation
Potential Chronic Health Effects:
Chronic overexposure may have skin, GI, and vascular effects.
Section 3: Composition/Information on Ingredients COMPONENT: CAS NO. % WT Section 4: First Aid Measures Eyes: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to open eyelids and then “roll” eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must seek medical attention if any adverse effect continues after rinsing. Skin: If adverse skin effects occur, discontinue use. Seek medical attention. Ingestion: If this product is swallowed, call physician or poison control center for most current information. If professional advice is not available, do not induce vomiting. Never induce vomiting or give diluents (milk or water) to someone who is unconscious, having convulsions, or unable to swallow. If victim is convulsing, maintain an open airway and obtain immediate medical attention. PAGE 1 OF 5 Safety Data Sheet Lidocaine Ointment 5%, USP SDS DATE: 9/22/11
Inhalation: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use artificial respiration to support vital functions. Seek medical attention if adverse effect continues after removal to fresh air. Section 5: Fire-Fighting Measures Flammable/Explosive Limits:
Water Spray, Carbon Dioxide, Foam, Dry Chemical, Halon
Special Fire Fighting Measures:
Incipient fire responders should wear eye protection. Structural firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. If protective equipment is contaminated by this product, it should be thoroughly washed with running water prior to removal of SCBA respiratory protection. Firefighters whose protective equipment becomes contaminated should thoroughly shower with warm, soapy water and should receive medical evaluation if they experience any adverse effects.
Unusual Fire and Explosion Hazards:
This product is combustible. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon oxides and nitrogen oxides). The Lidocaine component of this product is a skin sensitizer, and so it poses a contact hazard to firefighters.
Section 6: Accidental Release Measures General Information:
Proper protective equipment should be used. In the event of a spill, clear the area and protect people. T
Prevent material from entering sewer or confined spaces, waterways, soil or public waters.
Process for cleaning and take-up:
Small Spills: Wear goggles and gloves while wiping up small spills of this product with polypad or sponge.
Large Spills: Trained personnel following pre-planned procedures should handle non-incidental releases. Access to the spill area should be restricted. Protective apparel should be used with a respirator when there is any danger of mists or sprays being generated. Minimum Personal Protective Equipment should be rubber gloves, rubber boots, face shield, and Tyvek suit. The dispersal of mists or sprays into surrounding air and the possibility of inhalation is serious matter and should be treated as such. Absorb spilled liquid using polypads or other suitable absorbent material.
Decontaminate the area of the spill thoroughly using detergent and water. Place all spill residue in an appropriate container and seal. Dispose of in accordance with applicable Federal, State, and local procedures. (see Section 13, Disposal Considerations).
Section 7: Handling and Storage Handling: Handling advice:
As with all chemicals, avoid getting this product on your in you. Do not eat, drink, smoke, or apply cosmetics while handling this product. Wash hands thoroughly after handling this product or equipment and containers that contain this product. Follow specific use instructions supplied with this product. Particular care in working with this product must be practiced in pharmacies and other preparation areas, during manufacture of this product, and during patient administration.
Fire and explosion protection:
Keep away from heat, spark, and open flames.
Store this product away from incompatible materials. Store this product in original container.
PAGE 2 OF 5 Safety Data Sheet Lidocaine Ointment 5%, USP SDS DATE: 9/22/11 Section 8: Exposure Controls/Personal Protection Exposure Guidelines: Not established Engineering Controls: Ventilation:
Use with adequate ventilation. Follow standard medical product handling procedures.
Personal Protection: Respiratory Protection:
A respirator is not required for routine conditions of use of this product. If respiratory protection is needed, use only respiratory protection authorized in the U.S. Federal OSHA Respiratory Protection Standard (29 CFR 1910.134), equivalent U.S. State standards, or Canadian CSA Standard Z94.4-02.
For situations in which prolonged skin contact is anticipated, double glove, using latex, nitrile, or rubber gloves. Check gloves for leaks. Wash hands before putting on gloves and after removing gloves. Gloves should cover the gown cuff.
During patient administration, use of lightweight cotton gown or other medical attire is recommended.
Section 9: Physical and Chemical Properties General description: State: Ointment Odor: Peppermint Color(s): White Designation: Boiling Point: Freezing/Melting Point: Vapor Pressure: Specific Gravity @ 20ºC (water=1): Section 10: Stability and Reactivity Stability: Dangerous decomposition products:
No decomposition if used according to specifications.
Reactivity: Materials to avoid:
Acids, caustics, and other chemicals that could affect its performance should be avoided.
Conditions to avoid:
Avoid heat, light, and contact with materials listed to avoid.
PAGE 3 OF 5 Safety Data Sheet Lidocaine Ointment 5%, USP SDS DATE: 9/22/11 Section 11: Toxicological Information General toxicological information:
Individuals who have had allergic reactions to products containing the active ingredient, Lidocaine, other amide-type local anesthetics, or any other components of this product may experience allergic reactions to this product. Symptoms described in patients given therapeutic doses of this substance include the following: numbness and irritation.
The toxicity data available for the active component of this product, Lidocaine, is presented in this MSDS. Additional data are available for the excipient components of this product, but are not presented in this MSDS.
LIDOCAINE: LIDOCAINE (continued): LIDOCAINE (continued): TDLo (Oral-Child) 21 mg/kg: Behavioral: TDLo (Subcutaneous-Human) 33.3 µg/kg: TDLo (Intravenous-Mammal) 182.5 convulsions or effect on seizure threshold; Behavioral: analgesia mg/kg/72 hrcontinuous: Brain & Coverings: Vascular: BP lowering not characterized in LD50 (Oral-Rat) 317 mg/kg other degenerative changes autonomic section; Lungs, Thorax, or LD50 (Oral-Mouse) 220 mg/kg: Behavioral: TDLo (Intraperitoneal-Rat) 2 mg/kg: Blood Respiration: respiratory depression convulsions or effect on seizure threshold, TDLo (Oral-Child) 300 mg/kg/5 days- rigidity (including catalepsy); Lungs, TDLo (Subcutaneous-Mouse) 50 mg/kg: intermittent: Behavioral: convulsions or Thorax, or Respiration: respiratory Peripheral Nerve and Sensation: local effect on seizure threshold; Vascular: BP stimulation anesthetic4 lowering not characterized in autonomic LD50 (Intraperitoneal-Rat) 133 mg/kg: TDLo (Parenteral-Rat) 6.67 mg/kg: section; Nutritional and Gross Metabolic: Behavioral: somnolence (general Peripheral Nerve and Sensation: local body temperature increase depressed activity), convulsions or effect anesthetic TDLo (Oral-Woman) 39 mg/kg: Behavioral: on seizure threshold; Lungs, Thorax, or TDLo (Parenteral-Rat) 6 mg/kg: female 11 hallucinations, distorted perceptions, Respiration: other changes days after conception: Reproductive: excitement; Cardiac: change in rate LD50 (Intraperitoneal-Mouse) 102 mg/kg: Effects on Newborn: sex ratio TDLo (Intraspinal-Woman) 1 mL/kg: Peripheral Nerve & Sensation: local TDLo (Parenteral-Rat) 6 mg/kg: female 18 Behavioral: euphoria, hallucinations, anesthetic; Behavioral: convulsions or days after conception: Reproductive: distorted perceptions effect on seizure threshold, ataxia Effects on Newborn: behavioral TDLo (Intravenous-Woman) 16 mg/kg: LD50 (Subcutaneous-Rat) 335 mg/kg TDLo (Intramuscular-Rat) 50 mg/kg/3 days- Cardiac: change in rate; Respiration: LD50 (Subcutaneous-Mouse) 238 mg/kg intermittent: Blood: change in clotting LD50 (Subcutaneous-Guinea Pig) 120 factors; Immunological Including Allergic: TDLo (Intravenous-Man) 8643 µg/kg/4 increased immune response; hourscontinuous: Behavioral: toxic LD50 (Intravenous-Rat) 18 mg/kg Biochemical: Enzyme inhibition, induction, psychosis LD50 (Intravenous-Mouse) 20 mg/kg: or change in blood or tissue levels: TDLo (Intravenous-Man) 1700 µg/kg/2 Behavioral: convulsions or effect on multiple enzyme effects minutescontinuous: Behavioral: coma; seizure threshold; Vascular: BP lowering TDLo (Intramuscular-Rat) 6 mg/kg: female Cardiac: pulse rate; Respiration: not characterized in autonomic section; 11 day(s) after conception: Reproductive: respiratory depression Lungs, Thorax, or Respiration: other Effects on Newborn: behavioral TDLo (Intravenous-Human) 23 mg/kg: TDLo (Intraspinal-Rabbit) 5 mg/kg: Behavioral: LD50 (Intravenous-Mouse) 39.4 mg/kg Peripheral Nerve and Sensation: local muscle contraction or spasticity; Lungs, LD50 (Unreported-Rat) 39,400 µg/kg anesthetic Thorax, or Respiration: dyspnea LDLo (Intravenous-Rabbit) 41 mg/kg TDLo (Intradermal-Rabbit) 0.024 mg/kg: TDLo (Parenteral-Human) 0.71 mg/kg: LDLo (Intravenous-Guinea Pig) 65 mg/kg Behavioral: general anesthetic, analgesia Peripheral Nerve and Sensation: local TDLo (Intradermal-Rabbit) 0.024 mg/kg TDLo (Implant-Rat) 7500 mg/kg: female 3-17 anesthetic; Vascular: BP lowering not TDLo (Intravenous-Rat) 5 mg/kg: Vascular: day(s) after conception: Reproductive: characterized in autonomic section BP lowering not characterized in Effects on Fetus: fetotoxicity (except death, TDLo (Parenteral-Woman) 0.95 mg/kg: autonomic section e.g., stunted fetus) Peripheral Nerve and Sensation: local TDLo (Intravenous-Rat) 2343 µg/kg/5 TDLo (Unreported-Rat) 0.5 pph: Peripheral anesthetic; Vascular: regional or general minutes: Cardiac: change in rate Nerve and Sensation: local anesthetic arteriolar constriction TDLo (Intravenous-Rat) 4688 µg/kg/5 TDLo (Unreported-Guinea Pig) 0.25 pph: TDLo (Parenteral-Woman) 540 µg/kg: minutes: Vascular: BP lowering not Peripheral Nerve and Sensation: local female 39 week(s) after conception: characterized in autonomic section anesthetic Reproductive: Specific Developmental TDLo (Intravenous-Dog) 2 mg/kg: Cardiac: TDLo (Unreported-Frog) 0.1 pph: Peripheral Abnormalities: Central Nervous change in rate Nerve and Sensation: local anesthetic TDLo (Intravenous-Dog) 5 mg/kg: Vascular: TCLo (Inhalation-Rabbit) 10,000 gm/m TDLo (Skin-Woman) 1.72 mg/kg: Peripheral measurement of regional blood flow 3: Lungs, Thorax, or Respiration: structural Nerve and Sensation: local anesthetic; or functional change in trachea or bronchi Vascular: regional or general arteriolar Mutation in Micro constriction Section 12: Ecological Information General ecological information:
PAGE 4 OF 5 Safety Data Sheet Lidocaine Ointment 5%, USP SDS DATE: 9/22/11 Section 13: Disposal Considerations Waste disposal of product:
Waste disposal must be in accordance with appropriate U.S. Federal, State, and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves, and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents. Incineration is recommended. Reusable equipment should be cleaned with soap and water.
Section 14: Transport Information U.S. Department of Transportation Shipping Regulations:
This product is not classified as hazardous under regulations of U.S. DOT 49 CFR 172.101
Transport Canada Transportation of Dangerous Goods Regulations:
This product is not classified as Dangerous Goods, per regulations of Transport Canada.
Section 15: Regulatory Information United States Regulations: U.S. SARA Reporting Requirements: The components of this product are not subject to the reporting requirements of Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act. U.S. SARAThreshold Planning Quantity: There are no specific Threshold Planning Quantities for any component of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000 lb (4,540 kg) therefore applies, per 40 CFR 370.20. U.S. CERCLA Reportable Quantities (RQ): Not applicable. U.S. TSCA Inventory Status: This product is regulated by the Food and Drug Administration; it is not subject to requirements under TSCA. California Safe Drinking Water And Toxic Enforcement Act (Proposition 65): The components of this product are not on the California Proposition 65 lists. Other U.S. Federal Regulations: Not applicable. Canadian Regulations: Canadian DSL/NDSL Inventory Status: This product regulated by the Therapeutic Products Programme (TPP) of Health Canada and so it is exempt from requirements of the DSL/NDSL Inventory. Canadian Environmental Protection Act (CEPA) Priorities Substances Lists: The components of this product are not on the CEPA Priorities Substances Lists. Other Canadian Regulations: Not applicable. Canadian WHMIS Classification and Symbols: Class D2B Poisonous and infectious material (Sensitization Section 16: Other Information All information, recommendations, and suggestions appearing herein concerning our product are based upon tests and data believed to be reliable. However, it is the user’s responsibility to determine the safety, toxicity, and suitability for his own use of the product described herein. Since the actual use by others is beyond our control, no guarantee, express or implied, is being made as to the effects of such use, the results obtained, or the safety and toxicity of the product nor is there any assumed liability arising out of use, by others, of the product referred to herein. The information herein is not to be construed as absolutely complete since additional information may be necessary or desirable when particular or exceptional conditions or circumstances exist or because of applicable laws or government regulations. PAGE 5 OF 5
Title. This short tile of this initiative shall be and the initiative may be enacted as “The Hailey Medical Marijuana Act.” Findings. The people of Hailey, Idaho find as follows: WHEREAS the National Academy of Sciences’ Institute of Medicine concluded after reviewing relevant scientific literature including dozens of works documenting marijuana’s therapeutic value,1 that there are some