MSDS# 06A Lidocaine Ointment USP, 5% (March 31, 2006) Page 1 of 4 MATERIAL SAFETY DATA SHEET Manufacturer's Name: ALTANA INC. Divisions: E. FOUGERA & CO. DIVISION PHARMADERM DIVISION Street Address: 60 BAYLIS ROAD City, State, Zip Code: MELVILLE, NEW YORK 11747 Emergency Telephone No.: (800) 424-9300, (631) 454-7677 SECTION 1: IDENTITY Product Name: Synonyms: CAS #: Chemical Family: Formula: Lidocaine Ointment USP, 5% Lignocaine Ointment 5% Not applicable. Topical anesthetic in polyethylene glycol. Lidocaine USP, Polyethylene Glycol 300 NF, Polyethylene Glycol 1450. SECTION 2: SAFETY and HAZARD RATINGS Health (Acute-Chronic): Flammability: Reactivity: Environment (Air-Water-Soil): Special Hazards: Protective Equipment: 2–1 10 0–1–0 None. General ventilation, eye and hand wash. RATINGS Minimal 0 Slight 1 Moderate 2 Severe 3 Extreme 4 SECTION 3: EMERGENCY and FIRST AID PROCEDURES Eyes: Skin: Ingestion: Inhalation: Flush eyes with plenty of water for at least 15 minutes. Wash thoroughly with soap and water. Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person. Remove to fresh air. If breathing is difficult, give oxygen. If breathing has stopped, give artificial respiration. CALL A PHYSICIAN CONTACT A POISON CONTROL CENTER SECTION 4: INGREDIENTS CARCINOGEN HAZARD DATA NAME CAS# % IARC NTP OSHA ACGIH TLV OSHA PEL Lidocaine Polyethylene Glycol 300 Polyethylene Glycol 1450 137-58-6 25322-68-3 25326-68-3 5.0 no no no no no no no no no not established not established not established MSDS# 06A Lidocaine Ointment USP, 5% (March 31, 2006) Page 2 of 4 SECTION 5: FIRE and EXPLOSION HAZARD DATA Flash Point: Auto-ignition Temperature NF: Flammable Limits in Air by Volume LEL: UEL: Extinguishing Media: Special Fire Fighting Procedures: Unusual Fire and Explosion Hazards: Not determined. Not determined. Not determined. Not determined. Alcohol foam, Dry chemical, Carbon dioxide, Water spray. Use self-contained breathing apparatus and protective clothing. May emit toxic fumes of carbon oxides. SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS) Stability: [ X ] Stable [ ] Unstable Conditions and Chemicals to Avoid: Avoid heat, light, oxidants and bases. Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide. Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur SECTION 7: HEALTH HAZARDS Primary Route(s) of Entry: Signs and Symptoms of Exposure a. Overexposure Effects: b. Chronic Effects: 1. Inhalation: 2. Eyes: 3. Skin: 4. Ingestion: 5. Medical Conditions Potentially Aggravated: Dermal, Ingestion. a. May cause methemoglobinuria, depression of blood vessel tone and central nervous system effects. 1. Not likely due to the physical state of the product. 2. Will cause irritation. Do not use in the eyes. 3. None expected under normal conditions of use. 4. May cause gastrointestinal and vascular effects. 5. May cause skin irritation and allergies in sensitive individuals. Carcinogenicity studies on polyethylene (19,157,79) have been reviewed by IARC who found that they do not permit an evaluation of its carcinogenicity. SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES Precautions to be Taken in Handling/Storage: Keep container closed when not in use. Store at controlled room temperature 15N–30NC (59N–86NF). Avoid strong acids, alkalies, oxidizers and sources of heat. Hygienic Practices: Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin. Use general ventilation to protect your lungs. Do not wear contaminated clothing until thoroughly laundered. When Material is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash area with soap and water. Dispose of in accordance with federal, state and local regulations. Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at approved incineration or chemical landfill waste disposal site. MSDS# 06A Lidocaine Ointment USP, 5% (March 31, 2006) Page 3 of 4 SECTION 9: SPECIAL PROTECTION INFORMATION Respiratory Protection: Skin Protection: Eye Protection: Other Protective Clothing or Equipment: General ventilation. Normal hygiene. Normal hygiene. As needed to prevent repeated/prolonged contact. SECTION 10: CONTAINERS and LABELING Special Precautions: Recommended Container: Protect the Container by: Container Should be Handled in an Area With: The Empty Container is: Precautionary Label: Warning Placard: IMO Hazard Class #: UN/NA #: Hazard Classification: DOT Name: Shipping Instructions: Keep container closed when not in use. Store at controlled room temperature 15N–30NC (59N–86NF). Avoid strong acids, alkalies, oxidizers and sources of heat. As supplied (not sold in bulk quantity). Avoid physical damage, heat and light. Adequate general ventilation. Not reusable. Federal law prohibits dispensing without a prescription. For external use only. Do not use in the eyes. Keep out of reach of children. Not recommended for use by expectant mothers. Not applicable. Not applicable. Not applicable. Not applicable. Avoid strong acids, alkalies, oxidizers and sources of heat. SECTION 11: ENVIRONMENTAL RISKS Aquatic Toxicity: Biodegradability: Partition Coefficient: Not indicated. Not indicated. Not indicated. SECTION 12: REGULATORY INFORMATION Refer to the following references: OSHA Regulations: DOT Regulations: EPA Regulations: Other: If respirator used, 29 CFR 1910.134 Not applicable. Not applicable. NDC: 0168-0204-37 MSDS# 06A Lidocaine Ointment USP, 5% (March 31, 2006) Page 4 of 4 SECTION 13: PHYSICAL DATA Appearance and Odor: Molecular Weight: pH: Refractive Index @ 20NC: Viscosity CPS @ 25NC: Boiling Point: Freezing/Melting Point: Congealing Point: Vapor Pressure (mm Hg @ 20NC): Vapor Density (Air=1): Solubility in Water: Solubility in Alcohol: Solubility in Oil: 2 Specific Gravity @ H 0=1): % Volatile by Volume: Evaporation Rate (Ether=1): A white ointment that is essentially odorless. Not applicable. Not determined. Not determined. Not determined. 225NC (437NF) 40NC (104NF) Not determined. Not determined. Not determined. Soluble. Soluble. Slightly soluble. 1.053 @ 20NC 0 0.00 Date of Preparation/Change: March 21, 2006 Revision # 1 Replaces March 21, 2003 The information presented herein relates to the specific material described and may not be valid for this material used in combination with any other materials or in any process. This information is, to the best of our knowledge, accurate and reliable on the date compiled. We make no representation, warranty or guarantee as to its accuracy, reliability or completeness. It is the reader's responsibility to ascertain whether the information supplied is suitable and complete for that person's specific uses. This Material Safety Data Sheet was prepared for ALTANA INC. by: COMPLIANCE INNOVATIONS, INC. 706 Route 15 South, Suite 207 Lake Hopatcong, New Jersey 07849 973-663-1120 • fax 973-663-2378 helpdesk@chemply.com