MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COM PANY DIVISION
PHARM ADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
Emergency Telephone No.: (631) 454-7677
SECTION 1: IDENTITY
Product Name: Bacitracin Zinc Polymyxin B Sulfate Ointment USP (Double Antibiotic Ointment)
Synonyms: Double Antibiotic Ointment.
CAS #: Not applicable.
Chemical Family: Antibacterial ointment.
Formula: Bacitracin Zinc, Polymyxin B Sulfate and W hite Petrolatum.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 0-1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-0 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 if directed by medical personnel. 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
CARCINOGEN HAZARD DATA
ACGIH OSHA
NAME CAS# % IARC NTP OSHA TLV PEL
Bacitracin Zinc 1405-87-4 no no no not established
Polymyxin B Sulfate 1405-20-5 no no no not established
W hite Petrolatum 8009-03-8 no no no not established
M SDS# 04A Bacitracin Zinc Polymyxin B Sulfate Ointment USP (Double Antibiotic Ointment) (October 25, 2004) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
199 oC (390 oF) Closed Cup
Flash Point:
Auto-ignition Temperature oF: Not applicable.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: M ay emit toxic or irritant fumes when heated.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid extreme heat, oxidizers, strong acids and alkalies.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] M ay Occur [ X ] W ill Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. Allergy, kidney and liver impairments, dizziness, uncoordination, sensory loss and
deafness.
b. Chronic Effects: b. M ay produce hypersensitivity reactions.
1. Inhalation: 1. None expected under normal condition of use.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause kidney, liver and gastrointestinal impairment. M ay induce dizziness,
uncoordination, sensory loss and deafness.
5. M edical Conditions 5. Allergic reaction 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 extreme heat, oxidizers, strong acids
Handling/Storage: and alkalies.
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# 04A Bacitracin Zinc Polymyxin B Sulfate Ointment USP (Double Antibiotic Ointment) (October 25, 2004) 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: None.
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Avoid extreme heat, oxidizers, strong
acids and alkalies.
Recommended Container: As supplied. (Not sold in bulk quantity.)
Protect the Container by: Avoid physical damage and heat.
Container Should be Handled in an Area with: Cool, dry conditions.
The Empty Container is: Not reusable.
Precautionary Label: For external use only. Not for ophthalmic use.
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 sources of heat, oxidizers, strong acids and alkalies.
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
NDC: 0168-0021-09
0168-0021-31
0168-0021-35
M SDS# 04A Bacitracin Zinc Polymyxin B Sulfate Ointment USP (Double Antibiotic Ointment) (October 25, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A pale yellow ointment with no discernible odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity CPS @ 25 oC: Not determined.
>250 oC (>482 oF)
Boiling Point:
55 oC (131 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: Partially soluble.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Partially soluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1) <1
% Volatile by Volume: 0.0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 2 Replaces
October 25, 2004 M arch 30, 1992
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# 04A Bacitracin Zinc Polymyxin B Sulfate Ointment USP (Double Antibiotic Ointment) (October 25, 2004) Page 4 of 4
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