MATERIAL SAFETY DATA SHEET
Issued: 09/07/94 Prepared by: Gary Wong
Revised: 01/29/02 Manager EHS
Revision: 01 Core No. 242
1. PRODUCT AND COMPANY IDENTIFICATION
Tobramycin Ophthalmic Solution USP, 0.3%
Product Name:
Same
Generic Name:
24208-290-05 (5 ml)
NDC No.
Prescription only medicine, filled inside plastic bottle suitable
Legal Category:
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Aminoglycoside antibiotic/antibacterial
BAUSCH & LOMB PHARMACEUTICALS, INC.
8500 Hidden River Parkway
Tampa, FL 33637
Information: (800) 323-0000 (M-F) 8am-5pm EST
Emergency: (800) 227-1427 24 hrs
2. COMPOSITION/INFORMATION ON INGREDIENTS
3 3
Description CAS # TLV (mg/m ) PEL(mg/m ) % Content
Tobramycin 32986-56-4 NE NE 0.3
Boric Acid 10043-35-3 NE NE >1
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Sodium Sulfate Decahydrate, Tyloxapol,
Benzalkonium Chloride
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Tobramycin Ophthalmic Solution USP, 0.3%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle packed in a cardboard carton. Clear, colorless to pale yellow,
solution.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: This is an ophthalmic preparation. May cause irritation and hypersensitivity in
some individuals. Adverse reactions include localized ocular toxicity, lid itch and
swelling and redness of the mucous membrane of the eye (conjunctival erythema).
These reactions occur in less than 3% of patients. Signs of overdose of Tobramycin
Ophthalmic Solution include inflammation of the cornea (punctate keratitis),
erythema, increased tearing (lacrimation), swelling (edema) and lid itching.
Skin: May cause irritation. Repeated or prolonged contact can induce
hypersensitivity (anaphylactic) in some individuals.
Ingestion: May cause irritation and hypersensitivity in some individuals. Ingestion of
large quantities can cause nausea and vomiting.
Inhalation: May cause irritation to the respiratory tract and hypersensitivity in some
individuals.
Chronic Effects: May cause irritation and hypersensitivity (anaphylactic) in some
individuals. Prolonged use of topical antibiotics can give rise to overgrowth of
nonsusceptible organisms, including fungi. Bacterial resistance to tobramicin may
also develop.
Target Organs: Eyes, skin and digestive tract.
Medical Conditions Aggravated by Long Term Exposure: Allergies to
aminoglycoside antibiotics or any component of the product. As with other antibiotic
preparations, prolonged use may result in overgrowth of other nonsusceptible
organisms, including fungi. ppropriate measures should be taken if this occurs.
Reproduction studies, in three different types of animals, at doses up to thirty-three
times the normal human systemic dose have revealed no evidence of impaired
fertility or harm to the fetus due to tobramycin. There are no adequate and well
controlled studies in pregnant women. Tobramycin should be used in pregnancy
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Tobramycin Ophthalmic Solution USP, 0.3%
only if the potential benefits justify the risk to the fetus. Because of the potential for
adverse reactions in nursing infants from Tobramycin Ophthalmic Solution, a
decision should be made whether to discontinue nursing the infant or discontinue
taking the drug, taking into account the importance of the drug to the mother.
4. FIRST AID MEASURES
Eyes: If not prescribed this medication, rinse immediately with copious amounts of
water for at least 20 minutes. Contact a physician.
Skin: Remove all contaminated clothing and wash skin with copious amounts of
water for at least 20 minutes. Contact physician if skin becomes irritated.
Ingestion: Wash out mouth and give plenty of water and bland fluids. Seek
professional assistance.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician immediately.
Note to Physicians: Erythromycin is excreted in breast milk, so caution should be
exercised when administered to nursing mothers.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Toxic Fumes.
Extinguishing Media: Dry chemical, carbon dioxide, halon, water spray or fog, and
foam on surrounding materials.
Fire Fighting Instructions: Wear self-contained breathing apparatus and protective
clothing. Use water spray to keep fire-exposed containers cool. Do not spray water
into the burning material.
6. ACCIDENTAL RELEASE MEASURES
Large/Small Spills: Use personal protective equipment. Contain the spill to
prevent drainage into sewers, drains or streams. Use absorbent material to solidify
the spill. Shovel or scoop up solidified waste. Dispose of material according to
Federal, State and Local regulations.
7. HANDLING AND STORAGE
Handling: Avoid contact with product and use caution to prevent puncturing
containers. No special protective equipment or procedures are required in the
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Tobramycin Ophthalmic Solution USP, 0.3%
clinical or home environment.
Storage: Store product upright in original containers with the cap tightly closed at a
0 0 0 0
controlled room temperature 15 -30 C (59 - 86 F). KEEP THIS AND ALL DRUGS
OUT OF THE REACH OF CHILDREN.
8. EXPOSURE CONTROL/PERSONAL PROTECTION
Engineering Controls: In the manufacturing plant, provide adequate ventilation for
the raw material handling and compounding process which will maintain the dust
and vapor levels below the TLV, STEL, and PEL values for the ingredients.
Ventilation fans should be explosion proof. Use adequate personal protective
equipment e.g. NIOSH-approved respirators, goggles or safety glasses, gloves and
protective clothing. Ensure training in the handling of chemical material and use
current Material Safety Data Sheets.
Eye Protection: (29 CFR 1910.133) Recommend goggles or chemical safety
glasses.
Skin Protection: Thick impermeable gloves and protective clothing.
Respiratory Protection: (29 CFR 1910.134) NIOSH approved respirator, with
organic vapor, acid gas and HEPA filter recommended for handling raw materials.
Warning: Do not use air purifying respirators in oxygen depleted
environments. No respiratory protection is required in the clinical or home
environment.
Other: None
Ventilation: Recommended
Contaminated Equipment: Wash contaminated clothing separately. Wash
equipment with soap and water. Release rinse water into an approved wastewater
system or according to Federal, State and Local regulations.
9. CHEMICAL & PHYSICAL PROPERTIES
Appearance & Odor: Clear, colorless, to pale yellow solution.
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Miscible Percent Volatile by Volume: <1
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Tobramycin Ophthalmic Solution USP, 0.3%
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: Emits toxic fumes.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
Summary of Risks: Toxicological information refers to raw materials product.
Concentrations and toxicological effects are substantially reduced in the product.
For more detailed information see MSDS on chemical material.
CAS #
32986-56-4 Tobramycin
May cause irritation to the eyes, skin and respiratory tract. Can cause
hypersensitivity (anaphylactic) in some individuals. May cause localized ocular
toxicity including itching, swelling and conjunctival erythema. Intravenous-rat LD50
104 mg/kg.
10043-35-3 Boric Acid
Inhalation may cause coughing and chest discomfort. Prolonged skin contact can
cause burns and sensitization. Ingestion can cause nausea and vomiting.
Swallowing large quantities may be fatal and chronic exposure can cause central
nervous system stimulation and skin redness or rash. Oral-rat LD50 2660 mg/kg,
Inhalation-rat LC50 >16 mg/L.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations.
The method typically used is incineration.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Tobramycin Ophthalmic Solution USP, 0.3%
RCRA Hazardous Waste: Not Listed
EPA Designations:
Not Listed
SARA Title III:
14. TRANSPORTATION INFORMATION
Not classified as hazardous by DOT regulations.
Transportation Data:
15. REGULATORY INFORMATION
Not classified as hazardous by DOT regulations.
DOT Designations:
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
Prescription only medication.
FDA Designations:
NDC No. 24208-290-05 (5 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
CALIFORNIA PROPOSITION 65: Not Listed
16. OTHER INFORMATION
None
The information contained herein is furnished without warranty of any kind. The
above information is believed to be correct but does not purport to be all-inclusive
and should be used only as a guide. Users should make independent
determinations of the suitability and completeness of information from all sources to
assure proper use and disposal of these materials and the safety and health of
employees and customers.
NA 鈥? Not Applicable
NE - Not Established
< - Less Than
> - Greater Than
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