MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. DIVISION
PHARM ADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Dibucaine Ointment USP, 1%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Analgesic Ointment in Emollients.
Formula: Dibucaine USP, W hite Petrolatum, Anhydrous Lanolin, W ater and Acetone Sodium Bisulfate.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 2鈥?1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0鈥?1鈥?0 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: W ash thoroughly with soap and water.
Ingestion: Give two glasses of water and induce vomiting. Never give anything by mouth to an unconscious person.
Inhalation: 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
C A R C IN O G E N H A ZA R D D A T A
A C G IH O SH A
NAM E C A S# % IA R C NTP O SH A TLV PEL
Dibucaine 85-79-0 1.0 no no no not established
White Petrolatum 8009-03-8 no no no not established
Anhydrous Lanolin 8006-54-0 no no no not established
Water 7732-18-5 no no no not established
Acetone Sodium Bisulfate 540-92-1 no no no not established
M SDS# 05A Dibucaine Ointment USP, 1% (September 1, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature oF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes of Carbon monoxide and Carbon dioxide.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidizers, strong acids and bases, sources of heat and
light.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause skin irritation. M ay produce cardiovascular and central nervous system
effects.
b. Chronic Effects b. M ay produce skin reactions, cardiovascular and central nervous system effects.
1. Inhalation: 1. None expected under normal condition of use.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. No effects expected under normal conditions of use. M ay produce hypersensitivity
reactions after repeated applications.
4. Ingestion: 4. M ay cause nausea, vomiting and diarrhea.
5. M edical Conditions 5. M ay cause irritation of the skin in sensitive individuals.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid strong oxidizers, strong acids and bases,
sources of heat and light. Store between 15 o 鈥?30 oC (59 o鈥?86 oF).
Handling/Storage:
Hygienic Practices: W ash 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.
W hen M aterial is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove.
W ash area with soap and water. Dispose of in accordance with federal, state and local
regulations.
W aste Disposal M ethods: Assure conformity with applicable disposal regulations. Dispose of absorbed material
at approved incineration or chemical landfill waste disposal site.
M SDS# 05A Dibucaine Ointment USP, 1% (September 1, 2005) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Avoid strong oxidizers, strong acids
and bases, sources of heat and light. Store between 15 o 鈥?30 oC (59 o鈥?86 oF).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, heat and light.
Container Should be Handled in an Area with: General ventilation.
The Empty Container is: Not reusable.
Precautionary Label: For external use only. Not for ophthalmic use. (See package insert.)
W arning Placard: Keep out of reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Avoid strong oxidizers, strong acids and bases, sources of heat and light.
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORM ATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 330.5
NDC: 0168-0046-31
M SDS# 05A Dibucaine Ointment USP, 1% (September 1, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A pale yellow ointment with a slight lanolin odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
100 oC (212 oF)
Boiling Point:
43 oC (109 oF)
Freezing/M elting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Insoluble.
Solubility in Alcohol: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not indicated.
0.80 @ 20 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: 5鈥?10
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 2 Replaces
September 1, 2005 September 18, 2002
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. W e 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 M aterial Safety Data Sheet was prepared for ALTANA INC. by:
COM PLIANCE INNOVATIONS, INC.
706 Route 15 South, Suite 207
Lake Hopatcong, New Jersey 07849
973-663-1120 鈥? fax 973-663-2378
helpdesk@chemply.com
M SDS# 05A Dibucaine Ointment USP, 1% (September 1, 2005) Page 4 of 4
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