MATERIAL SAFETY DATA SHEET
Issued: 09/07/94 Prepared by: Gary Wong
Revised: 03/26/02 Manager EHS
Revision: 02 Core No. 124
1. PRODUCT AND COMPANY IDENTIFICATION
Antipyrine and Benzocaine Otic Solution USP
Product Name:
Same
Generic Name:
24208-561-62 (10 ml)
NDC No.
Prescription only medicine, filled inside glass bottle suitable
Legal Category:
for dispensing, and overpacked inside a cardboard carton.
Drug Composition: Local anesthetic combination
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
Antipyrene 60-80-0 NE NE 5.4
Benzocaine 94-09-7 NE NE 1.4
Glycerin 56-81-5 NE NE >1
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Oxyquinolin Sulfate
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MSDS: Antipyrine and Benzocaine Otic Solution USP
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Amber glass bottle in a cardboard box. Clear yellow, very viscous solution with a
characteristic odor.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: May cause irritation to the mucous membranes and hypersensitivity. Repeated
or prolonged exposure can cause conjunctivitis.
Skin: May cause irritation and hypersensitivity in some individuals. Repeated or
prolonged exposure can cause dermatitis.
Ingestion: May cause irritation and hypersensitivity. Moderately toxic by ingestion,
but large quantities may induce headache, dizziness, drowsiness, insomnia,
vomiting, diarrhea, kidney failure and numbness in nose and throat.
Inhalation: May cause irritation and hypersensitivity. Inhalation of vapors, given off
at high temperatures, can cause defatting and irritation of the mucous membranes.
Chronic Effects:
路 Antipyrene may cause methemoglobinemia (low blood oxygen levels). After
repeated exposures, skin rashes can develop which may last for several weeks.
路 May cause hypersensitivity in some individuals.
Target Organs: Respiratory and digestive tract and kidneys.
Medical Conditions Aggravated by Long Term Exposure:
路 Individuals sensitive to ester-type local anesthetics (e.g. butacaine, butamben,
chloroprocaine, tetracaine, propoxycaine) or to PABA may be hypersensitive to
antipyrene and benzocaine.
路 It is not known if Antipyrine and Benzocaine Otic Solution can cause fetal harm
or impair reproductive capacity. This medication should only be given to pregnant
women if clearly needed.
路 It is not known if this drug is excreted in human milk, so caution should be
exercised when administering this medication.
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MSDS: Antipyrine and Benzocaine Otic Solution USP
4. FIRST AID MEASURES
Eyes: If not prescribed this medication, 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 give plenty of water and bland fluids. Seek
professional assistance.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician immediately.
Note to Physicians: None
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: Toxic Fumes and acrolein.
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
0 0 0 0
controlled room temperature 15 -30 C (59 - 86 F). KEEP THIS AND ALL DRUGS
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MSDS: Antipyrine and Benzocaine Otic Solution USP
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 yellow very viscous solution with a characteristic odor.
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Soluble Percent Volatile by Volume: <1
10. STABILITY AND REACTIVITY
Chemical Stability: Stable
Conditions to avoid: Extreme heat or cold.
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MSDS: Antipyrine and Benzocaine Otic Solution USP
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 and acrolein.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
Summary of Risks: Toxicological information refers to the raw materials of the
product. Concentrations and toxicological effects are substantially reduced in the
product. For more detailed information see MSDS on chemical material.
CAS #
60-80-0 Antipyrine
May cause irritation and hypersensitivity (anaphylactic). Individuals sensitive to other
local anesthetics, such as benzocaine, may also be allergic to antipyrine. May cause
methemoglobinemia. Repeated exposure can cause skin rashes which may last for
several weeks. Studies indicate probability of toxicity by ingestion, inhalation and
skin contact. Oral-rat LD50 1800 mg/kg. IV-mouse LD50 500 mg/kg.
94-09-7 Benzocaine
May cause irritation to eyes, skin and respiratory tract, and cause hypersensitivity
(anaphylactic) in some individuals. Effects include numbness in nose and throat,
drowsiness and dizziness. Can cause central nervous system stimulation. Persons
sensitive to other ester-type local anesthetics (e.g. butacaine, butamben,
chlorocaine, tetracaine, propoxycaine) or PABA may also be sensitive to
benzocaine. Oral-rabbit LD50 1159 mg/Kg.
56-81-5 Glycerin
May cause irritation to eyes and skin. Repeated or prolonged exposure may 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.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
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BAUSCH & LOMB Pharmaceuticals Division
MSDS: Antipyrine and Benzocaine Otic Solution USP
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
Prescription only medication.
FDA Designations:
NDC No. 24208-561-62 (10 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
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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