MATERIAL SAFETY DATA SHEET
Issued: 09/07/04 Prepared by: Gary Wong
Revised: 03/30/05 Manager EHS
Revision: 01 Core No. 107
1. PRODUCT AND COMPANY INFORMATION
Product Name: Nystatin Oral Suspension
Generic Name: Nystatin Oral Suspension, USP
100,000 units per ml
NDC No. 24208-960 鈥? 94, 473 ml
24208-960 鈥? 67, 60 ml
Legal Category: Prescription only medicine, filled inside glass or plastic bottle
suitable for dispensing, and overpacked inside a cardboard
carton.
Drug Composition: Antifungal/antibiotic
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)
Description CAS # % Content
Nystatin, USP 1400-61-9 NE NE >3
Glycerin, USP 56-81-5 10 NE >1
Sodium Citrate, USP 6132-04-3 NE NE >1
Sucrose, NF 57-50-1 NE 15 >1
Ingredients <1%, Cherry Flavor, Citric Acid, Methylparaben, Peppermint Flavor,
Propylparaben, Carboxymethylcellulose Sodium
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BAUSCH & LOMB INCORPORATED
MSDS: Nystatin Oral Suspension, USP
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Glass or plastic bottle in a cardboard carton. Orange, viscous suspension, with slightly
sweet, cherry odor. Oral medication only. May irritate eyes. On decomposition product
may liberate acrolein (107-02-8 TLV=0.23 mg/m3).
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POTENTIAL HEALTH HAZARDS
Carcinogenicity: (NTP) No (IARC) No (OSHA) No
Eye: May cause irritation and hypersensitivity (anaphylactic) in some individuals.
Skin: May cause irritation and hypersensitivity (anaphylactic) in some individuals.
Ingestion: This is an oral preparation and may cause hypersensitivity in some
individuals. Ingestion of large doses has occasionally caused diarrhea,
gastrointestinal distress, nausea, and vomiting.
Inhalation: May cause irritation to the respiratory tract and hypersensitivity in some
individuals.
Chronic Effects: Nystatin is virtually nontoxic and nonsensitizing and is tolerated by
all age groups including infants, even on prolonged administration.
Target Organs: Gastrointestinal tract
Medical Conditions Aggravated by Long Term Exposure: Hypersensitivity to any
of the components of the product.
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.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician.
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BAUSCH & LOMB INCORPORATED
MSDS: Nystatin Oral Suspension, USP
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: Toxic fumes, sulfur oxides (SOx), acrolein (107-02-8
TLV=0.23 mg/m3).
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.
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.
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BAUSCH & LOMB INCORPORATED
MSDS: Nystatin Oral Suspension, USP
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: Yellow-orange, viscous suspension, with a slightly sweet cherry
odor.
Boiling Point: NE Evaporation Rate: e.g. water
Specific Gravity: >1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Immiscible Percent Volatile by Volume: <1
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: Toxic fumes, sulfur oxides (SOx), acrolein
(107-02-8 TLV=0.23 mg/m3).
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 #
1400-61-9 Nystatin
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BAUSCH & LOMB INCORPORATED
MSDS: Nystatin Oral Suspension, USP
May cause irritation to mucous membranes and hypersensitivity
(anaphylactic) in some individuals. Possible allergic reaction when in
contact with eyes, skin, digestive and respiratory tract.
56-81-5 Glycerin
May cause irritation to eyes and skin. Repeated or prolonged exposure can
cause dermatitis and eye conjunctivitis. Inhalation is not likely due to low
evaporation rate, but fumes may cause irritation and defatting of the tissues.
Ingestion can cause headache, restlessness, insomnia, dizziness, vomiting,
diarrhea, and fever. Large doses can cause hemolysis, hemoglobinuria,
hyperglycemia, glycosuria, renal failure, convulsions, narcosis and paralysis.
Oral-rat LD50 12,600 mg/kg. Decomposition releases corrosive fumes of
acrolein. Avoid open flame and extreme heat. Incompatibilities include strong
acids, strong oxidizers, metal oxides and metal hydrides.
6132-04-3 Sodium Citrate
May cause irritation to eyes, skin, respiratory and digestive tract. Target
organs are the central nervous system, kidneys and bones. Increased risk
persons have impaired renal function, dehydration, sodium restricted diets or
hypertension. This information may be based on general information
regarding sodium salts. Ingestion of large doses can cause nausea,
vomiting, convulsions, diarrhea and hypernoia (hyper mental activity or
imagination). Chronic exposure can cause urolithiasis (build-up of calcium
deposits in the urinary tract) due to increased extraction of calcium from the
bones.
57-50-1 Sucrose
This substance is considered to be non-toxic. Oral-rat LD50 29.7 gm/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.
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BAUSCH & LOMB INCORPORATED
MSDS: Nystatin Oral Suspension, USP
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. 24208-960 鈥? 94, 473 ml
24208-960 鈥? 67, 60 ml
OSHA Designations: (29 CFR 1910.1000, Table Z)
Nystatin-Not Listed, Glycerin-Listed, Sodium Citrate-Not
Listed, Sucrose-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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