Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
Effective Date: 12/16/08 Supersedes: None Page 1 of 9
Section 1: IDENTIFICATION
PRODUCT:
Product Name: Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile)
Product Description: Multiple dose antibiotic and steroid combination
Product Code(s):
NDC No(s): NDC 24208-295-25 (2.5mL)
NDC 24208-295-05 (5 mL)
NDC 24208-295-10 (10 mL)
Intended Use: For topical ophthalmic use
COMPANY IDENTIFICATION:
Bausch & Lomb, Incorporated
1400 N. Goodman Street
Rochester, New York 14609
For Information: 1-800-553-5340
EMERGENCY TELEPHONE NUMBER:
24-Hour Emergency: 1-800-535-5053
Section 2: HAZARD(S) IDENTIFICATION
EMERGENCY OVERVIEW
Caution!! Pharmacologically Active Material. Tobramycin and
Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile) is
a multiple dose antibiotic and steroid combination for topical
ophthalmic use. Do Not Use if there exists hypersensitivity to any
ingredient in this product. WARNING: Keep out of reach of
children.
PRECAUTIONS:
Caution!! Pharmacologically Active Material. Tobramycin and dexamethasone ophthalmic suspension is
indicated for steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where
superficial bacterial ocular infection or a risk of bacterial ocular infection exists. FOR TOPICAL OPHTHALMIC
USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in
some patients. If a sensitivity reaction does occur, discontinue use. If you are sensitive to any of its components,
do not use. Use only in accordance with label instructions and supplied product literature.
KEEP OUT OF REACH OF CHILDREN.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 2: HAZARDS IDENTIFICATION (cont.)
POTENTIAL HEALTH EFFECTS
EYE:
The most frequent adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity,
including lid itching and swelling, and conjunctival erythema. Refer to product literature for additional information.
SKIN:
Not expected to be irritating to skin or mucous membranes when used as directed.
INGESTION:
Not expected to be an exposure route. However, may cause gastric and intestinal irritation if ingested.
INHALATION:
Not expected to be a significant exposure route. Vapor or mist may be irritating to mucous membranes and upper
respiratory tract.
CHRONIC HEALTH EFFECTS
Refer to the product literature for all product warnings.
CARCINOGENICITY / MUTAGENICITY:
No studies have been conducted to evaluate the carcinogenic or mutagenic potential of Tobramycin and
Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile)
NTP: NA
IARC: NA
OSHA: NA
IMPAIRMENT OF FERTILITY:
No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100
mg/kg/day.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 3: COMPOSITION / INFORMATION ON INGREDIENTS
Reportable Hazardous Substances:
CAS # Chemical Identitiy % W/W
32986-56-4 Tobramycin, USP 0.3
50-02-2 Dexamethasone, USP 0.1
8001-54-5 Benzalkonium Cloride Solution, NF 50% 0.01
25301-02-4 Tyloxapol, USP Trade Secret
6381-92-6 Edetate Disodium Dihydrate, USP Trade Secret
7647-14-5 Sodium Chloride Trade Secret
9004-62-0 Hydroxyethyl Cellulose, NF Trade Secret
7757-82-6 Sodium Sulfate (Anhydrous), USP Trade Secret
7732-18-5 Purified Water, USP Balance
pH balanced with Sodium Hydroxide and/or Sulfuric Acid.
Section 4: FIRST AID MEASURES
INHALATION:
Normal use of this product does not pose an inhalation hazard. However, should respiratory tract irritation develop,
discontinue use and remove to fresh air. Get medical attention if irritation or other symptoms develop or persist.
SKIN CONTACT:
Should irritation develop, discontinue use. Wash affected skin thoroughly with soap and water. Get medical attention if
irritation or other symptoms develop or persist.
EYE CONTACT:
Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Get medical attention.
INGESTION:
If swallowed, DO NOT induce vomiting. Seek medical attention immediately.
Section 5: FIRE FIGHTING MEASURES
EXTINGUISHING MEDIA:
Carbon dioxide, dry chemical powder, appropriate foam or water fog.
HAZARDOUS COMBUSTION PRODUCTS:
During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.
SPECIAL FIRE FIGHTING INSTRUCTIONS:
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 5: FIRE FIGHTING MEASURES (cont.)
As in any fire, wear self-contained breathing apparatus and full protective gear to prevent contact with skin and eyes.
Section 6: ACCIDENTAL RELEASE MEASURES
PERSONAL PRECAUTIONS:
Wear suitable protective eyewear, clothing, respiratory protection, rubber boots and rubber gloves.
Shut off all sources of ignition. Evacuate immediate area. Ensure adequate ventilation. Refer to Sections 7 and 8.
ENVIRONMENTAL PRECAUTIONS:
Prevent spilled material from entering storm sewers or drains, waterways, and contact with soil.
METHODS AND MATERIALS FOR CONTAINMENT AND CLEANING UP:
Large Spill (> 4 liters):
Isolate hazard area. Prevent from entering drains and sewers. Cover with vermiculite or other suitable inert material, pick
up and place in closed containers. Transport outdoors and hold for waste disposal. Ventilate area and wash spill site
after material pickup is complete.
Small Spill (< 4 liters):
Isolate hazard area. Prevent from entering drains and sewers. Cover with vermiculite or other suitable inert material, pick
up and place in closed containers. Transport outdoors and hold for waste disposal. Ventilate area and wash spill site
after material pickup is complete.
Refer to Section 13 for appropriate disposal procedures.
Section 7: HANDLING AND STORAGE
HANDLING:
Use only in accordance with label instructions and supplied product literature.
Bulk Operations
Avoid contact with eyes. Avoid prolonged or repeated exposure to skin or mucous membranes, and breathing
mists/vapors. Use in a well ventilated area, away from all ignition sources. Wash thoroughly with soap and water after
handling.
STORAGE:
Store upright at 20?- 25癈 (68?- 77癋) [See USP Controlled Room Temperature]. Shake well before using.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
CONTROL PARAMETERS:
OCCUPATIONAL EXPOSURE LIMITS / GUIDELINES
OSHA PEL ACGIH TLV NIOSH REL IRELAND HSE
CAS # COMPONENT NAME TWA /STEL TWA /STEL TWA /STEL TWA /STEL TWA /STEL UNITS
32986-56-4 Tobramycin, USP NE NE NE NE NE NE NE NE NE NE NA
50-02-2 Dexamethasone, USP NE NE NE NE NE NE NE NE NE NE NA
8001-54-5 Benzalkonium Cloride Solution, NF 50% NE NE NE NE NE NE NE NE NE NE NA
25301-02-4 Tyloxapol, USP NE NE NE NE NE NE NE NE NE NE NA
6381-92-6 Edetate Disodium Dihydrate, USP NE NE NE NE NE NE NE NE NE NE NA
7647-14-5 Sodium Chloride NE NE NE NE NE NE NE NE NE NE NA
9004-62-0 Hydroxyethyl Cellulose, NF NE NE NE NE NE NE NE NE NE NE NA
7757-82-6 Sodium Sulfate (Anhydrous), USP NE NE NE NE NE NE NE NE NE NE NA
7732-18-5 Purified Water, USP NE NE NE NE NE NE NE NE NE NE NA
N/E: Not Established OSHA: Occupational Safety & Health Administration
TWA: 8-Hour Time-Weighted Average PPM: Parts Per Million
N/A: Not Applicable STEL: Short-Term Exposure Limit
ACGIH: American Conference of Governmental Industrial Hygienists C: Ceiling Limit
NIOSH: National Institute for Occupational Safety & Health REL: Recommended Exposure Limit
NOTE: Limits/standards shown for guidance only. Follow applicable regulations.
ENGINEERING CONTROLS:
Use with good general ventilation. No special controls required.
RESPIRATORY PROTECTION:
No special controls or personal protection required under conditions of intended use.
In the event of a spill, a NIOSH-certified air-purifying respirator with organic vapor cartridges may be permissible under
certain circumstances where airborne concentrations are expected to exceed exposure limits and when adequate oxygen
is present. Use a positive pressure air-supplied respirator if there is any potential for an uncontrolled release or any other
circumstances where air purifying respirators may not provide adequate protection.
EYE PROTECTION:
No special controls or personal protection required under conditions of intended use.
In the event of a spill, appropriate eye protection should be worn.
SKIN PROTECTION:
No special controls or personal protection required under conditions of intended use.
In the event of a spill, use rubber gloves.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 8: EXPOSURE CONTROLS / PERSONAL PROTECTION (cont.)
ADDITIONAL PROTECTIVE CLOTHING & EQUIPMENT:
NA
Section 9: PHYSICAL AND CHEMICAL PROPERTIES
Liquid
Physical State:
White suspension
Color:
No Odor
Odor:
Not determined
Odor Threshold:
~ 5.8
pH-Value:
Not applicable
Melting Point:
Not determined
Freezing Point:
Not determined
Initial Boiling Point:
Not applicable
Flash Point:
Not determined
Evaporation Rate:
Not applicable
Flammability (solid,gas):
Not determined
Explosion Limits:
Not determined
Vapor Pressure:
Not determined
Vapor Density:
~ 1.00
Specific Gravity (H2O=1):
Dexamethasone: Soluble in ethanol, acetone, chloroform
Solubility:
Not applicable
Partition Coefficient:
Not determined
Auto-Ignition Temperature:
Not determined
Decomposition Temperature:
Not determined
Viscosity:
Section 10: STABILITY AND REACTIVITY
REACTIVITY:
No known hazards.
CHEMICAL STABILITY:
Stable under normal conditions.
POSSIBILITY OF HAZARDOUS REACTIONS:
None are known.
CONDITIONS TO AVOID:
Excessive heat or cold. Refer to Section 7, Handling and Storage.
INCOMPATIBLE MATERIALS:
Refer to product literature.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 10: STABILITY AND REACTIVITY (cont.)
HAZARDOUS DECOMPOSITION:
None known
Section 11: TOXICOLOGICAL INFORMATION
RTECS No.: WK2100000
Tobramycin
ORL-RAT LD50: 7500 MG/KG
Toxicity Data:
RTECS No.: TU3980000
Dexamethasone
ORL-RAT LD50: >3 GM/KG
Toxicity Data:
RTECS No.: BO3150000
Benzalkonium Chloride
ORL-RAT LD50: 240 MG/KG
Toxicity Data:
RTECS No.: SM9750000
Tyloxapol
ORL-RAT LD50: > 5 GM/KG
Toxicity Data:
RTECS No.: AH4375000
Edetate Disodium Dihydrate
ORL-RAT LD50: 2000 MG/KG
Toxicity Data:
RTECS No.: VZ4725000
Sodium Chloride
ORL-RAT LD50: 3000 MG/KG
Toxicity Data:
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
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Section 11: TOXICOLOGICAL INFORMATION (cont.)
RTECS No.: FJ5958000
Hydroxyethyl Cellulose
ORL-RAT LD50: Not Determined
Toxicity Data:
RTECS No.: WE1650000
Sodium Sulfate (Anhydrous)
ORL-MOUSE LD50: 5989 MG/KG
Toxicity Data:
NOTE: Only selected Registry of Toxic Effects of Chemical Substances (RTECS) data is presented here. See
actual entry in RTECS for complete information.
Section 12: ECOLOGICAL INFORMATION
No specific ecological data are available for this product.
Section 13: DISPOSAL CONSIDERATIONS
All disposal methods must be in compliance with all Federal, State/Provincial and local laws and regulations. Regulations
may vary in different locations. Waste characterizations and compliance with applicable laws are the sole responsibility of
the waste generator.
Section 14: TRANSPORT INFORMATION
US DOT IATA IMO RID/ADR Canadian DG
No Information No Information No Information
Shipping Name: Not Regulated Not Regulated
Available Available Available
Hazard Class: NA NA
UN Number: NA NA
Package Group: NA NA
There are no unreasonable risks (health, safety, or property), that this product would pose when transported in commerce.
Hazard class definitions (49 CFR, Part 173) are not applicable to this product.
Tobramycin and Dexamethasone Ophthalmic Suspension USP,
0.3%/0.1% (Sterile)
MATERIAL SAFETY DATA SHEET
Page 9 of 9
Section 15: REGULATORY INFORMATION
OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200):
Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile) is considered hazardous under the
Occupational Safety & Health Administration Hazard Communication Standard.
TOXIC SUBSTANCE CONTROL ACT (TSCA):
All components are listed or are exempt from listing on the TSCA Inventory.
SARA TITLE III (Superfund Amendments and Reauthorization Act):
SECTION 302 (Extremely Hazardous Substances): No Components Listed
SECTION 311, 312 (Hazard Categories): Acute, Chronic
SECTION 313 (Toxic Chemicals): No Components Listed
CALIFORNIA PROPOSITION 65:
This product contains no listed substances known to the State of California to cause cancer, birth defects or other
reproductive harm, at levels which would require a warning under the statute.
Section 16: OTHER INFORMATION
To the best of our knowledge, the information contained herein is accurate. However, neither Bausch & Lomb
Incorporated nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All
materials may present unknown hazards and should be used with caution. Although certain hazards are described
herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF
MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Bausch & Lomb Incorporated or any of its
subsidiaries be liable for any special, incidental or consequential damages.
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