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
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Acetate
Ophthalmic Ointment USP
Synonyms: Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment.
CAS #: Not applicable.
Chemical Family: Pharmaceutical ointment primarily composed of alkanes.
Formula: Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Hydrocortisone Acetate, W hite Petrolatum and
M ineral Oil.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-0-1 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
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
Bacitracin Zinc 1405-89-6 no no no not established
Polymyxin B Sulfate 1405-20-5 no no no not established
Neomycin Sulfate 1405-10-3 no no no not established
Hydrocortisone Acetate 50-03-3 no no no not established
White Petrolatum 8009-03-8 no no no not established
Mineral Oil 8042-47-5 no no no not established
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SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature 0F: 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: W ear full protective clothing and self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes, Carbon oxides (CO, CO 2) in a fire.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidizers, strong acids, bases and sources of heat.
Hazardous Combustion or M ay emit toxic fumes when burned.
Decomposition Products:
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. May cause skin irritation.
b. Chronic Effects: b. Prolonged use may result in intraoccular pressure, glaucoma, optic nerve damage, posterior
subcapsular cataract formation, and allergic reactions in sensitive individuals. Secondary
infections may occur through the combined use of steroids and antimicrobials. Carcinogenicity
studies on highly refined mineral oils (IARC Monographs Suppl. 7, 252, 1987) have been
reviewed by IARC who found that they 鈥渄o not permit an evaluation of its carcinogenicity.鈥?
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. None expected under normal conditions of use. Prolonged use may result in intraoccular
pressure, glaucoma, optic nerve damage and posterior subcapsular cataract formation.
3. Skin: 3. May cause irritation.
4. Ingestion: 4. May cause indigestion, nausea and vomiting.
5. Medical Conditions 5. May cause allergic reaction and skin irritation to individuals sensitive to any cortisone drug
Potentially Aggravated: or the antibiotic components.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not handle or store near strong oxidizers,
strong acids, bases and sources of heat. Store at controlled room temperature 15 o-
Handling/Storage:
30 oC (59 o-86 oF).
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.
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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,
bases and sources of heat. Store at controlled room temperature 15 o-30 oC
(59 o-86 oF).
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: Federal law prohibits dispensing without a prescription. Use as directed. For
external use only. (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: No applicable.
Shipping Instructions: Keep aw ay from strong oxidizers, strong acids, bases and sources of heat.
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 448.313b
NDC: 0168-0029-38
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SECTION 13: PHYSICAL DATA
Appearance and Odor: A pale yellow ointment with no discernible odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
Approximately 149 oC (300 oF)
Boiling Point:
57 oC (134.6 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: M ainly insoluble.
Solubility in Oil: M ainly soluble.
Solubility in Other: Not determined.
0.86 @ 20 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 2 Replaces
October 25, 2004 M arch 25, 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
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