Page 1 of 4 3/20/2006
MATERIAL SAFETY DATA SHEET
Product Name: LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION 4% NDC Product(s) Code(s): 60432-465-50
Prep. Date: 05/11/04 Prepared By: LEW 1. Manufacturer: Morton Grove Pharmaceuticals, Inc. 6451 W. Main Street Morton Grove, IL 60053 Emergency Telephone: (847) 967-5600 (800) 346-6854 2. Product Identification: Product Name: Product NDC Code: Chemical Family: Synonym(s): Product Category: LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION 4% 60432- 465-50 Liquid/Mixture Xylocaine Topical Solution 4% Local Anesthetic (Topical)
3. Composition/ Ingredient Information: Each mL contains: Actives: Lidocaine Hydrochloride 40 mg
Other Ingredients: Purified Water; Propylene Glycol; Methyl paraben; Sodium Hydrochloride for pH adjustment. Physical and Chemical Properties: Appearance: Odor: pH Range: Specific Gravity: Boiling Point: Evaporation Rate: Clarity: Vapor Density: Colorless Odorless 5.0-7.0 1.01 Not Determined Slower than Ether Clear Heavier than air
Page 2 of 4 3/20/2006
4. Stability and Reactivity: Stability: Physical conditions to avoid: Incompatibility with other materials: Hazardous Decomposition Products: Hazardous Polymerization: 5. Hazards Identification: Primary Route(s) of Exposure: Effects of Over Exposure: Threshold Limit Value: Side Effects: May include any of the following: Rash; Hives; swelling or abnormal sensation at the site of application. Possible Adverse Effects: Chest tightness; shortness of breath; wheezing; swelling of the eyelids, face or lips; stuffy nose; itching; rash. Symptoms of Overdose: Blurred or double vision; confusion; numb; twitching; vomiting; dizziness; trouble breathing; restlessness; timidness. Dermal N/A N/A Stable Excessive Heat None None Will not occur
6. Emergency and First-Aid Measures: Skin Contact: Remove any contaminated clothing immediately. Wash affected areas with soap and large amounts of water. Eye Contact: Immediately flush eyes with water and continue flushing for several minutes. Seek medical attention.
Inhalation: Remove to fresh air; get medical attention for any breathing difficulty.
Page 3 of 4 3/20/2006
Excess Ingestion: See section 6 under “Symptoms of Overdose.” Contact a doctor or poison control.
7. Fire Fighting Measures: Flammability Classification: Flash Point: Lower Explosion Limit: Upper Explosion Limit: Extinguishing Media: Fire Fighting Measures: Unusual Fire or Explosion Hazards: 8. Toxicological Information: CAUTION: Pregnancy: LIDOCAINE TOPICAL SOLUTION 4% IS NOT STERILE. Lidocaine has not been studied in pregnant women. Non-Flammable Not Determined Not Determined Not Determined Water Normal None
Nursing Mothers: Lidocaine is passed in breast milk in small amounts. Children: There are no Lidocaine studies done on children. Take the advice of your physician.
Adults/Geriatrics: There are no studies of Lidocaine Topical use in the elderly compared to the use in other age groups. 9. Spill and Leak Procedures: Steps to be taken if material is spilled: Contains Lidocaine HCL. Flush to sanitary system with copious amounts of water following local and federal requirements for disposal. 10. Waste Disposal Method: Dispose of this material in accordance with applicable international, national, state, and local waste regulations. 11. Storage and Handling Precautions: As with any drug/medicine, keep out of the reach of children. Store at a controlled room temperature, 15 °C - 30°C (59°F - 86°F). Dispense in tight, light resistant container. Store away from heat and direct light.
Page 4 of 4 3/20/2006
Always follow the advice of your physician while using this drug. Make sure your healthcare professional is aware of any allergies or any other medical problems that you may have.
12. Process Handling Precautions: A system of local exhaust is recommended to keep employee exposure below the airborne exposure limits. Local exhaust is usually preferred because it controls the emission at its source, preventing dispersion of it into the general work area. As a general rule, avoid all contact and inhalation of dust, mists, and/or vapors associated with this material. Wash thoroughly after handling. 13. Personal Protection/ Exposure Controls: Respiratory Protection: Ventilation: Protective Gloves: Eye Protection: Not required Local exhaust Yes Yes
14. Shipping Regulations (Ref: 49 CFR § 172.101): Proper Shipping Name: Hazard Class: UN/NA Number: Subsidiary Risk: US DOT Emergency Response Guide: Transportation Label Required: 15. Disclaimer: The contents of this MSDS are believed to be correct but do not purport to be all-inclusive and should only be used as a guide. Morton Grove Pharmaceuticals disclaims any express or implied warranty as to the accuracy of the above information and shall not be held liable for any direct, incidental or consequential damages resulting from reliance on the above information. Not regulated None None Listed None None None