MATERIAL SAFETY DATA SHEET
Issued: 09/07/94 Prepared by: Gary Wong
Revised: 01/25/02 Manager EHS
Revision: 01 Core No. 043
1. PRODUCT AND COMPANY IDENTIFICATION
Prednisolone Sodium Phosphate Ophthalmic Solution
Product Name:
USP,1.0%
Generic Name: Same
NDC No. 24208-715-02 ( 5 ml)
24208-715-10 (10 ml)
24208-715-06 (15 ml)
Prescription only medicine, filled inside a plastic bottle suitable
Legal Category:
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Glucocorticoid
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
Prednisolone sodium 125-02-0 NE NE 1.0
phosphate
Purified Water 7732-18-5 NE NE >1
Ingredients <1% Hydroxypropyl Methycellulose, Sodium Phosphate, Sodium
Chloride, Edetate Disodium, Benzalkonium Chloride
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Prednisolone Sodium Phosphate Ophthalmic Solution USP,1.0%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle in cardboard box. Clear, colorless to slightly yellow, odorless aqueous
solution. Toxic by ingestion.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: May cause irritation or burning sensation on installation and hypersensitivity
(anaphylactic) in some individuals. It has been shown, though not in humans, that
through large doses or prolonged topical administration, glucocorticoids may be
systemically adsorbed by pregnant mothers and produce fetal abnormalities.
Systematically administered corticosteroids are secreted into breast milk in
quantities not likely to have a deleterious effect on the infant. Systemic toxicity
reactions include reversible hypothalamic-pituitary-adrenal axis gland suppression,
manifestations of Cushing's syndrome, intercranial hypertension, hyperglycemia and
glycosuria.
Skin: May cause irritation and localized hypersensitivity in some individuals with
itching, swelling and diffused redness of the skin.
Ingestion: May cause irritation and hypersensitivity in some individuals. Large
doses may induce vomiting, diarrhea, adrenal gland suppression, Cushing's
syndrome, water retention, electrolyte imbalance and hyper-glycemia.
Inhalation: May cause irritation and hypersensitivity in some individuals.
Chronic Effects: May cause hypersensitivity. In the presence of dermatological
infections, the use of an appropriate antifungal or antibacterial agent should be
instituted. Manifestations of adrenal suppression in children include linear growth
retardation, delayed weight gain, low plasma cortisol levels and absence of
response to ACTH stimulation.
Target Organs: Eyes, skin, digestive tract, kidney and brain.
Medical Conditions Aggravated by Long Term Exposure: Anaphylactic cross-
reactions may occur for glucocorticoids. Preexisting conjunctival or systemic fungal
infections may be aggravated. Appropriate measures should be taken if this occurs.
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MSDS: Prednisolone Sodium Phosphate Ophthalmic Solution USP,1.0%
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. 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.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Emits toxic fumes.
Extinguishing Media: Dry chemical, carbon dioxide, halon, water fog and foam for
surrounding materials. Water spray will froth if sprayed into the burning material.
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
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MSDS: Prednisolone Sodium Phosphate Ophthalmic Solution USP,1.0%
0 0 0 0
controlled room temperature 15 -30 C (59 - 86 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
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: White aqueous suspension.
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
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
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MSDS: Prednisolone Sodium Phosphate Ophthalmic Solution USP,1.0%
Incompatibility: This product has the incompatibilities of water e.g. strong acids,
bases, alkali metals, alkali hydrides and silver preparations.
Hazardous Decomposition Products: Emits toxic fumes.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
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 #
125-02-0 Prednisolone Sodium Phosphate
May cause irritation to eyes, skin and respiratory tract. Prolonged or repeated
contact can cause hypersensitivity (anaphylactic) in some individuals. May cause
allergic reaction if inhaled, ingested or on contact with the skin. Adverse reactions
include suppression of adrenal gland secretion, Cushing's syndrome (fatigue, skin
discoloration, obesity), water retention, electrolyte imbalance, and hyper-glycemia.
Oral-mouse LD50 2.0 gm/kg.
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:
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MSDS: Prednisolone Sodium Phosphate Ophthalmic Solution USP,1.0%
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
Prescription only medication.
FDA Designations:
NDC No. 24208-715-02 ( 5 ml)
NDC No. 24208-715-10 (10 ml)
NDC No. 24208-715-06 (15 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
CALIFORNIA PROPOSITION 65: This product contains chemical(s) known to the
State of California to cause reproductive / developmental toxicity: CAS# 125-02-0,
listed as Prednisolone sodium phosphate.
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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