MATERIAL SAFETY DATA SHEET
Issued: 09/07/94 Prepared by: Gary Wong
Revised: 05/13/04 Manager EHS
Revision: 03 Core No. 034
1. PRODUCT AND COMPANY INFORMATION
Product Name: Neomycin and Polymyxin B Sulfates and Gramicidin
Ophthalmic Solution USP
Generic Name: Same
NDC No. 24208-790-62 (10 ml)
Legal Category: Prescription only medicine, filled inside a plastic bottle suitable
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Antibiotic combination
BAUSCH & LOMB INCORPORATED
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
TLV (mg/m3) PEL (mg/m3) % Content
Description CAS #
Gramicidin 1405-97-6 NE NE <1
Neomycin Sulfate 1405-10-3 NE NE <1
Polymyxin B Sulfate 1405-20-5 NE NE <1
Thimerosol 54-64-8 0.1 0.1 C 0.001
Ingredients <1% - Sodium Chloride, Alcohol, Polaxamer 188, Propylene Glycol
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle inside a cardboard box. Clear solution with a medicinal odor.
Contains thimerosal. Decomposition products are toxic fumes and mercury vapor.
Toxic by ingestion. For eyes only.
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POTENTIAL HEALTH HAZARDS
Carcinogenicity: (NTP) No (IARC) No (OSHA) No
Eye: Can cause redness, swelling, itching and localized hypersensitivity of the eye
and eyelids. This condition may be manifested as a failure to heal. This preparation
is for the eyes only.
Skin: Neomycin sulfate may cause sensitization of the skin. May cause irritation,
rash and hypersensitization.
Ingestion: May cause irritation and hypersensitization (anaphylactic). Large doses
may induce dizziness, sensory disturbances, thirst, vomiting, nausea, diarrhea and
skin rash.
Inhalation: Not likely with a liquid preparation. May cause irritation and
hypersensitization.
Chronic Effects: Possible hypersensitization to antibiotics, including cross-reactions
to kanamycin, paromomycin, streptomycin and possibly gentamicin.
Target Organs: Kidney, skin and brain.
Medical Conditions Aggravated by Long Term Exposure: Hypersensitivity to
Neomycin Sulfate, Polymyxin B Sulfate or any of the components of the product.
Anaphylactic cross-reactions may occur for antibiotics including kanamycin,
paromomycin, streptomycin and possibly gentamicin. As with other anti-microbial
preparations, prolonged use may result in overgrowth of nonsusceptible organisms
including fungi. Appropriate measures should be taken if this occurs. Patients with
chronic otitis medius may develop ototoxicity due to Neomycin.
4. FIRST AID MEASURES
Eyes: Rinse immediately with copious amounts of water for at least 20 minutes.
Contact a physician.
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
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 drink plenty of water and bland fluids. The use
of an emetic drug and/or gastric lavage is advisable. Do not give anything to an
unconscious person. Contact physician.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician.
Note to Physicians: Neomycin sulfate may cause sensitization of the skin. Can
cause localized hypersensitivity of the eye, eyelids and conjunctival erythema. This
condition may be manifested as a failure to heal. During long-term use of neomycin
containing products, periodic examination for such signs is advisable and the patient
should be told to discontinue using the product if the symptoms are confirmed. These
symptoms subside quickly on withdrawing the medication. Neomycin containing
applications should be avoided for the patient thereafter. Additional details are
available on the package insert or in the Physicians Desk Reference.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: When heated to decomposition, product emits Sulfur Oxides
(SOx), Nitrogen Oxides (NOx), Mercury Vapor (Hg), Sodium Oxides (Na2O).
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.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
Storage: Store product upright in original containers with the cap tightly closed at a
controlled room temperature 150-300 C (590- 860 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
contaminated 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 solution with a medicinal odor.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: When heated to decomposition, product
emits Mercury Vapor (Hg), Sulfur Oxides (SOx), Nitrogen Oxides (NOx), Sodium
Oxides (Na2O).
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY
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 #
1405-97-6 Gramicidin
May cause irritation of the skin, mucous membranes and respiratory tract. Prolonged
and repeated exposure can produce hypersensitivity (anaphylactic) in some
individuals. This material is not absorbed through the gut and presents no toxic
hazard except when in a diseased or perforated state. Parenteral- mouse 15
micrograms/kg; IV-mouse LD50 1500 micrograms/kg.
1405-10-3 Neomycin Sulfate
Prolonged or repeated contact can cause hypersensitivity (anaphylactic) in some
individuals. Individuals sensitive to one aminoglycoside antibiotic may also be
sensitive to neomycin sulfate. High level exposures may be toxic to kidneys
(nephrotoxicity) and may cause hearing difficulties (ototoxicity) and diminished
balance. Oral- rat LD50 2750 mg/kg.
1405-20-5 Polymyxin B Sulfate
May cause irritation to skin, mucous membranes and respiratory tract. Prolonged
and repeated contact can produce hypersensitivity (anaphylactic) in some individuals.
Overexposure may produce dizziness, diminished muscularcoordination, kidney
damage (nephrotoxicity), and sensory disturbances. This material is not readily
absorbed into the gut and so does not present a toxicological hazard. IV- mouse LD50
5.4 mg/kg, IP- mouse 20.5 mg/kg, Oral- mouse 790 mg/kg, SC- mouse LD50 59.5
mg/kg.
54-64-8 Thimerosal
May cause irritation to mucous membranes of lungs and eyes. Sensitization
dermatitis may occur in individuals previously exposed. Chemical burns can occur.
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
May cause conjunctivitis in cases of chronic exposure. Contains mercury. Toxic
by ingestion and possibly inhalation. Oral-rat LD50 75 mg/kg.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
EPA Designations: RCRA Hazardous Waste: Not Listed
SARA Title III: Not Listed
14. TRANSPORTATION INFORMATION
Transportation Data: Not classified as hazardous by DOT regulations.
15. REGULATORY INFORMATION
DOT Designations: Not classified as hazardous by DOT regulations.
EPA Designations: RCRA Hazardous Waste
(40 CFR 261.33) Not Listed
FDA Designations: Prescription only medication.
24208-790-62 (10 ml)
OSHA Designations: 29 CFR 1910.1000, Table Z
Mercury compounds listed
SARA TITLE III (Superfund Amendments and Reauthorization Act):
SECTION 302: Extremely Hazardous Substances: No Components Listed
SECTION 311, 312: Hazard Categories: NA
SECTION 313: Toxic Chemicals CAS# 54-64-8: Mercury compounds are
subject to the reporting requirements of Section 313 of SARA Title III.
CALIFORNIA PROPOSITION 65: This product contains chemical(s) known to the
State of California to cause reproductive / developmental toxicity: CAS# 54-64-8,
listed as mercury and mercury compounds.
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BAUSCH & LOMB INCORPORATED
MSDS: Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP
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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