MATERIAL SAFETY DATA SHEET
Issued: 04/26/04 Prepared by: Gary Wong
Revised: N/A Manager EHS
Revision: Original Core No. 435
1. PRODUCT AND COMPANY INFORMATION
Product Name: Ciprofloxacin Ophthalmic Solution USP, 0.3%
Generic Name: Ciprofloxacin Ophthalmic Solution USP, 0.3%
NDC No. 24208-444-25 (2.5 ml)
24208-444-05 ( 5 ml)
24208-444-10 ( 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 #
Ciprofloxacin 85721-33-1 NE NE 0.3%
Mannitol 69-65-8 NE NE 4.5%
Ingredients < 1% Edetate Disodium, Sodium Acetate Trihydrate, Glacial Acetic
Acid, Benzalkonium Chloride
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BAUSCH & LOMB INCORPORATED
MSDS: Ciprofloxacin Ophthalmic Solution USP, 0.3%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in a cardboard box. Clear, colorless 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: Ciprofloxacin 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 system.
Chronic Effects: Ciprofloxacin and related drugs have been shown to cause
arthropathy in immature animals of most species tested following oral
administration. However, a one-month topical ocular study using immature Beagle
dogs did not demonstrate any articular lesions.
Target Organs: No data.
Medical Conditions Aggravated by Long Term Exposure: Ciprofloxacin and
related drugs have been shown to cause arthropathy in immature animals of most
species tested following oral administration. However, a one-month topical ocular
study using immature Beagle dogs did not demonstrate any articular lesions.
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.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Ciprofloxacin Ophthalmic Solution USP, 0.3%
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: Reproduction studies have been performed in rats and
mice at doses up to six times the usual daily human oral dose and have revealed
no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits,
as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally)
produced gastrointestinal disturbances resulting in maternal weight loss and an
increased incidence of abortion. No teratogenicity was observed at either dose.
After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was
produced and no embryotoxicity or teratogenicity was observed. There are no
adequate and well controlled studies in pregnant women. Ciprofloxacin ophthalmic
solution USP, 0.3% should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether topically applied ciprofloxacin is
excreted in human milk; however, it is known that orally administered ciprofloxacin
is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in
human breast milk after a single 500 mg dose. Caution should be exercised when
ciprofloxacin ophthalmic solution USP, 0.3% is administered to a nursing mother.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: May emit 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.
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BAUSCH & LOMB INCORPORATED
MSDS: Ciprofloxacin 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 20-250 C (360- 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: Clear colorless 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: Ciprofloxacin 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: May emit toxic fumes.
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#
85721-33-1 Ciprofloxacin
Nausea, diarrhea, headache, restlessness, renal abnormalities and renal failure,
abnormalities of liver enzymes, jaundice, palpitations, tachycardia, arthralgia, tonic/
clonic seizures, central nervous system disturbances, dizziness, weakness,
irritability, malaise, photodermatitis, and hypersensitivity reactions. Ciprofloxacin
may also irritate the eyes, skin, and respiratory system. Acute toxicity: LD50 (oral,
rat) > 5,000 mg/kg. TDLo (oral, human 鈥? male) 200 mg/kg. TDLo (oral, human 鈥?
female) 200 mg/kg. Two out of eight mutatgenicity test were positive; however, the
following in vivo test systems were negative: rat hepatocyte DNA repair assay,
micronucleus test (mice), and dominant lethal test (mice).
69-68-5 Mannitol
Dusts, such as finely milled mannitol can irritate the upper respiratory tract in large
quantities, resulting in cough. Excessive ingestion of mannitol can cause irritation
of the stomach, as well as nausea and diarrhea. In extreme cases, vomiting, chills,
dizziness, chest pain, cardiac failure and pulmonary edema. Dermal exposure can
irritate and discolor the skin, particularly in sensitive areas.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
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BAUSCH & LOMB INCORPORATED
MSDS: Ciprofloxacin Ophthalmic Solution USP, 0.3%
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.
NDC No. 24208-444-25 (2.5 ml)
24208-444-05 ( 5 ml)
24208-444-10 ( 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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