MATERIAL SAFETY DATA SHEET
Issued: 09/07/94 Prepared by: Gary Wong
Revised: 01/28/02 Manager EHS
Revision: 01 Core No. 077
1. PRODUCT AND COMPANY IDENTIFICATION
Gentamicin Sulfate Ophthalmic Solution USP, 0.3%
Product Name:
Same
Generic Name:
24208-580-60 ( 5ml)
NDC No.
24208-580-64 (15ml)
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
Gentamicin Sulfate 1405-41-0 NE NE 0.3
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Sodium Phosphate, Benzalkonium Chloride
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Gentamicin Sulfate Ophthalmic Solution USP , 0.3%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in a cardboard box. Clear, colorless, odorless solution. For eyes only.
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POTENTIAL HEALTH HAZARDS
(NTP) No (IARC) No (OSHA) No
Carcinogenicity:
Eye: May cause irritation and hypersensitivity (anaphylactic) in some individuals.
May cause burning, swelling of the inner eyelid (non-specific conjunctivitis),
conjunctival epithelial defects, and increased blood flow in the inner eyelid
(conjunctival hyperemia). Other rare effects include an abnormal decrease in blood
clotting platelets with hemorrhages (thrombocytopenic purpura) and hallucinations.
Skin: May cause irritation, and repeated or prolonged contact can induce
hypersensitivity (anaphylactic) in some individuals.
Ingestion: May cause irritation and hypersensitivity in some individuals. Ingestion of
large quantities may induce gastric disturbances.
Inhalation: May cause irritation and induce hypersensitivity in some individuals.
Chronic Effects: May cause irritation and hypersensitivity (anaphylactic) in some
individuals. Prolonged use of topical antibiotics may give rise to overgrowth of
nonsusceptible organisms, including fungi. Bacterial resistance to gentamicin may
also develop. Bacterial and fungal corneal ulcers have developed during treatment
with gentamicin ophthalmic preparations.
Target Organs: Eyes, kidneys 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. Appropriate measures should be taken if this occurs.
Gentamicin has been shown to depress body weights, kidney weights and median
glomerular counts in newborn rats when administered systemically to pregnant rats
in daily doses. There are no adequate and well controlled studies in pregnant
women, so gentamicin should be used only if the potential benefits justify the risk to
the fetus.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Gentamicin Sulfate Ophthalmic Solution USP , 0.3%
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: Not for injection into the eye or introduction into the anterior
chamber of the eye.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Sulfur oxides (SOx), 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
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
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Gentamicin Sulfate Ophthalmic Solution USP , 0.3%
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, odorless 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
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
Incompatibility: This product has no incompatibilities except those of water e.g.
strong acids, bases, alkali metals, alkali hydrides.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Gentamicin Sulfate Ophthalmic Solution USP , 0.3%
Hazardous Decomposition Products: Toxic fumes, sulfur oxides (SOx).
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
Summary of Risks: Toxicological information refers to the raw materials of the
product. Concentrations and toxicological effects are substantially reduced in the
product. For more detailed information see MSDS on chemical material.
CAS#
1405-41-0 Gentamicin Sulfate
May cause irritation or allergic reactions by inhalation, ingestion, skin and eye
contact. Should be avoided by persons with an allergy to aminoglycoside antibiotics.
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.
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. 24208-580-60 ( 5 ml)
NDC No. 24208-580-64 (15 ml)
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Gentamicin Sulfate Ophthalmic Solution USP , 0.3%
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
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.
NE- Not Established
< - Less Than
> - Greater Than
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