Material safety data sheet page 1 of x

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

Emergency Information Chemtrec:
(800) 424-9300


Section 2: Hazards Identification
Emergency Overview

Warning:
Routes of Entry:

Potential Acute Health Effects:
Eyes:

Inhalation:

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:


Flash Point:


Method Used:


Extinguishing Media:

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
Environmental precautions:

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.
Storage:

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. Hand Protection:
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.
Eye Protection:


Body Protection:

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:


Decomposition advices:

No decomposition if used according to specifications.
Reactivity:
Materials to avoid:

Acids, caustics, and other chemicals that could affect its performance should be avoided.
Hazardous polymerization:


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.
Toxicity Data:

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. SARA Threshold 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

Source: http://staging.test.novocol.com/docs/msds/Lidocaine-Ointment.pdf