MATERIAL SAFETY DATA SHEET
Issued: 12/20/01 Prepared by: Gary Wong
Revised: NA Manager EHS
Revision: Original Core No. 397
1. PRODUCT AND COMPANY IDENTIFICATION
Cromolyn Sodium Nasal Solution USP (OTC)
Product Name:
Same
Generic Name:
57782-397-26 (26 ml)
NDC No.
Pharmaceutical preparation, filled inside plastic bottle with
Legal Category:
metering pump for dispensing, and overpacked inside a
cardboard carton.
Drug Composition: Antiallergenic (Mast cell stabilizer)
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
Cromolyn Sodium 15826-37-6 NE NE >1
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Edetate Disodium Dihydrate, Benzalkonium Chloride
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Cromolyn Sodium Nasal Solution USP (OTC)
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle packed in a cardboard box with metering pump. Clear, colorless
aqueous solution.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: May cause irritation, burning or stinging on installation. Can cause
hypersensitivity (anaphylactic) in some individuals. Adverse reactions which have
been reported as infrequent effects include conjunctival injection, watery eyes,
itchy eyes, dryness around the eye, puffy eyes, eye irritation and styes. It is
unclear if these effects are attributable to the drug.
Skin: May cause irritation and hypersensitivity in some individuals.
Ingestion: May cause irritation and hypersensitivity in some individuals.
Inhalation: May cause irritation and hypersensitivity in some individuals. Vapors
produced at controlled room temperature are negligible.
Chronic Effects: May cause hypersensitivity. Prolonged use can cause
conjunctival injection, watery eyes, itchy eyes, dryness around the eye, puffy eyes,
eye irritation and styes. It is unclear if these effects are attributable to the drug.
Target Organs: Eyes.
Medical Conditions Aggravated by Long Term Exposure: Hypersensitivity to
any of the components of the product.
路 Reproduction studies have been performed in rats, mice and rabbits up to 338
times the human clinical doses with no evidence of fetal malformations. Adverse
fetal effects (increased resorption and decreased fetal weight) were noted only at
the very high parental doses that produced maternal toxicity. There are,
however, no adequate and well controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this
drug should be used during pregnancy only if clearly needed.
路 Fertility studies of animals show no impaired fertility.
路 Mutagenesis studies of animals show no evidence of chromosomal damage.
路 It is not known if this drug is excreted in human milk, so caution should be
exercised when administering this or any drug to a nursing mother.
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MSDS: Cromolyn Sodium Nasal Solution USP (OTC)
路 Clinical and efficacy studies in children below the age of 4 years have not been
done.
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. Give plenty of water and bland fluids. Do not give
anything to an unconscious person. Contact physician.
Inhalation: Remove person to fresh air. If breathing stops, use artificial
respiration. Contact physician.
Note to Physicians: None
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Emits 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.
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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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Cromolyn Sodium Nasal Solution USP (OTC)
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: 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
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Cromolyn Sodium Nasal Solution USP (OTC)
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 #
15826-37-6 Cromolyn Sodium
May cause irritation to the mucous membranes of the eyes, skin or respiratory
tract. Can cause hypersensitivity (anaphylactic) in some individuals. Adverse
effects include throat irritation or dryness, bronchospasm, wheezing, coughing,
nausea, vomiting, headache and dizziness. Subcutaneous-mouse LD50 4400
mg/Kg, Intravenous-mouse LD50 3300 mg/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:
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Cromolyn Sodium Nasal Solution USP (OTC)
OTC
FDA Designations:
NDC No. 57782-397-26 (26 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: 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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