MATERIAL SAFETY DATA SHEET
Issued: 04/26/04 Prepared by: Gary Wong
Revised: N/A Manager EHS
Revision: Original Core No. 434
1. PRODUCT AND COMPANY INFORMATION
Product Name: Ofloxacin Ophthalmic Solution USP, 0.3%
Generic Name: Ofloxacin Ophthalmic Solution USP, 0.3%
NDC No. 24208-434-05 ( 5 ml)
24208-434-10 (10 ml)
Legal Category: Prescription only medicine, filled inside plastic bottle suitable
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Anti-Infective
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 #
Ofloxacin 82419-36-1 NE NE 0.3%
Ingredients < 1% Sodium Chloride, Benzalkonium Chloride
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BAUSCH & LOMB INCORPORATED
MSDS: Ofloxacin Ophthalmic Solution USP, 0.3%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in a cardboard box. Clear, greenish yellow aqueous solution. Presents
little or no hazards if spilled and no unusual hazard if involved in fire.
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POTENTIAL HEALTH HAZARDS
Carcinogenicity: (NTP) No (IARC) No (OSHA) No
Eye: May irritate the eyes.
Skin: Ofloxacin should be discontinued at the first appearance of a skin rash or
any other sign of hypersensitivity reaction.
Ingestion: No data.
Inhalation: May irritate the respiratory tract.
Chronic Effects: Refer to Section 11.
Target Organs: None
Medical Conditions Aggravated by Long Term Exposure: The systemic
administration of quinolones, including ofloxacin, has led to lesions or erosions of
the cartilage in weight-bearing joints and other signs of arthropathy in immature
animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day
in young dogs (equivalent to 110 times the maximum recommended daily adult
ophthalmic dose) has been associated with these types of effects. Quinolones,
including ofloxacin, have been shown to cause arthropathy in immature animals
after oral administration; however, topical ocular administration of ofloxacin to
immature animals has not shown any arthropathy. There is no evidence that the
ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.
4. FIRST AID MEASURES
Eyes: 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.
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BAUSCH & LOMB INCORPORATED
MSDS: Ofloxacin Ophthalmic Solution USP, 0.3%
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: Additional details are available on the package insert or in
the Physicians Desk Reference.
Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect
in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000
times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day
(equivalent to 1800 times the maximum recommended daily ophthalmic dose).
These dosages resulted in decreased fetal body weight and increased fetal
mortality in rats and rabbits, respectively. Minor fetal skeletal variations were
reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown
to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when
administered to pregnant rats and rabbits, respectively.
Nursing Mothers: In nursing women a single 200 mg oral dose resulted in
concentrations of ofloxacin in milk which were similar to those found in plasma. It is
not known whether ofloxacin is excreted in human milk following topical ophthalmic
administration. Because of the potential for serious adverse reactions from
ofloxacin in nursing infants, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug
to the mother.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Products of combustion may be toxic.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Ofloxacin Ophthalmic Solution USP, 0.3%
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
controlled room temperature 150-250 C (590- 770 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: Greenish yellow aqueous solution
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Complete Percent Volatile by Volume: <1
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BAUSCH & LOMB INCORPORATED
MSDS: Ofloxacin 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: Products of combustion may be toxic.
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 #
82419-36-1 Ofloxacin
May cause asthenia, malaise, seizures, anxiety, cognitive change, vertigo, cough,
bronchospasm, tachycardia, syncope, hepatic dysfunction, kidney dysfunction, and
hypersensitivity reactions. Irritating to the eye, nose, and throat. Acute toxicity:
LD50 (oral, rat) 3,590 mg/kg, TDLo (oral, male) 17 mg/kg/d, and TDLo (oral,
female) 24 mg/kg/d. Reproductive toxicity: Embryotoxic in rats (160 mg/kg/d) and
rabbits (810 mg/kg/d). Not teratogenic in rats and rabbits at 810 mg/kg/d.
Pregnancy category C.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Ofloxacin Ophthalmic Solution USP, 0.3%
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.
NDC No. 24208-434-05 ( 5 ml)
24208-434-10 (10 ml)
OSHA Designations: (29 CFR 1910.1000, Table Z)
Not Listed
SARA Title III: Not listed under Section 313 of Toxic Release Reporting.
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.
NE- Not Established
< - Less Than
> - Greater Than
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