MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
(800) 424-9300 , (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Neomycin Sulfate, Polymyxin B Sulfates and Bacitracin Zinc Ointment and Ophthalmic Ointment USP
Synonyms: 鈥淭riple鈥? Antibiotic Ointment.
CAS #: Not applicable.
Chemical Family: Antibiotic Ointment
Formula: Neomycin Sulfate Micronized USP Sterile, Polymyxin B Sulfate Micronized USP Sterile, Bacitracin Zinc Micronized
USP Sterile, and White Petrolatum USP. Ophthalmic ointment also contains Mineral Oil USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 1 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-0-3 Moderate 2
Special Hazards: Not indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EMERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes (non-ophthalmic form only).
Skin: Wash 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
Neomycin Sulfate 1405-10-3 no no no not established
Polymyxin B Sulfate 1405-20-5 no no no not established
Bacitracin Zinc 1405-89-6 no no no not established
White Petrolatum 8009-03-8 no no no not established
5mg/m3 * 5mg/m3*
Mineral Oil 8012-95-1 no no no
* as m ist
M SDS# 05A Neomycin Sulfate, Polymyxin B Sulfates and Bacitracin Zinc Ointment and Ophthalmic
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Ointment USP [March 16, 2005]
SECTION 5: FIRE and EXPLOSION HAZARD DATA
199o C (390o F) (closed cup) (97% Petrolatum Concentration)
Flash Point:
Auto-ignition Temperature oF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing Media: Alcohol Foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Wear full protective clothing.
Unusual Fire and Explosion Hazards: May emit toxic fumes.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid extreme heat, sparks, open flame, oxidizers, strong acids and alkalies.
Hazardous Combustion or Decomposition Carbon dioxide, Carbon monoxide.
Products:
Hazardous Polymerization: [ ] May Occur [ X ] Will 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 impairment, dizziness, uncoordination, sensory loss, deafness, nausea,
vomiting and diarrhea.
b. Chronic Effects: b. May cause allergic reactions in susceptible individuals.
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. Use only specified ophthalmic ointment in eyes. topical ointment will cause eye irritation.
3. Skin: 3. Non-toxic under standard application.
4. Ingestion: 4. May cause kidney, liver and gastrointestinal impairment; may induce dizziness,
5. Medical Conditions uncoordination, sensory loss and deafness.
Potentially Aggravated: 5. Allergic reaction in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store at controlled room temperature 15o-25oC
Precautions to be Taken in
(59o -77oF). Do not handle or store near heat, flame or oxidizers.
Handling/Storage:
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.
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Ointment USP [March 16, 2005]
SECTION 9: SPECIAL PROTECTION INFORMATION
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
Keep container closed when not in use. Store at controlled room temperature 15o-25oC
Special Precautions:
(59o-77oF).
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: Ophthalmic Ointment: Federal law prohibits dispensing without a prescription. For
ophthalmic use only. (See package insert.)
Warning Placard: Keep out of reach of children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from extreme heat, flame and oxidizers.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 300.5
21 CFR 369.21
NDC: 0168-0012-09 Ointment
0168-0012-35 Ointment
0168-0012-31 Ointment
0168-0027-38 Ophthalmic Ointment
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Ointment USP [March 16, 2005]
SECTION 13: PHYSICAL DATA
Appearance and Odor: A pale yellow ointment. Odorless.
Molecular Weight: Not applicable.
pH: Not determined.
Refractive Index @ 20oC: Not determined.
Viscosity: Not determined.
200oC (392oF)
Boiling Point:
58oC (136oF)
Freezing/Melting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20o C): <1mm
Vapor Density (Air=1): Not determined.
Solubility in Water: Insoluble.
Solubility in Alcohol: Practically insoluble.
Solubility in Oil: Soluble.
Solubility in Other: Most polar solvents.
0.85 @ 60oC
Specific Gravity (H2 0=1):
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 2 Replaces
March 16, 2005 November 29, 2001
previously known as Bacitracin Zinc-Neomycin
Sulfate-Polymyxin B Sulfate Ointment and
Ophthalmic Ointment
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 Neomycin Sulfate, Polymyxin B Sulfates and Bacitracin Zinc Ointment and Ophthalmic
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Ointment USP [March 16, 2005]
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