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MATERIAL SAFETY DATA SHEET
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic
Suspension USP
Revision Date: 02/20/2008
SECTION 1: PRODUCT IDENTIFICATION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic
Product Name
Suspension USP
Same as above
Common Name/Trade Name
Paddock Laboratories, Inc.
Manufacturer
NA
Synonyms
NA
Chemical Name
Chemical Family Antibiotic/Corticosteroid
NA
Chemical Formula
SECTION 2: COMPOSITION AND INGREDIENTS
CHEMICAL NAME CAS# % OSHA PEL ACGIH TLV
50-23-7 =1 NA NA
Hydrocortisone
1405-10-3 <1 NA NA
Neomycin Sulfate
1405-20-5 <1 NA NA
Polymyxin B Sulfate
36653-82-4 =1 NA NA
Cetyl Alcohol
9004-99-3 =1 NA NA
Polyoxyl 40 stearate
9005-65-6 1 NA NA
Polysorbate 80
0.1 mg (Hg)/m3 0.1 mg (Hg)/m3
54-64-8 0.01
Thimerosol
7732-18-5 =1 NA NA
Purified Water
SECTION 3: HAZARDS IDENTIFICATION
Paddock Laboratories, Inc. Page 1 of 9
Eye: Redness, swelling and itching of the eye. Not an
ophthalmic suspension. May cause hypersensitivity
in some individuals.
Skin: Rash, swelling and itching due to hyper-
sensitivity. Not a topical preparation. It has been
shown, though not in humans, that through large
doses or prolonged topical administration
adrenocorti-costeroids may be systemically adsorbed
by pregnant mothers and produce fetal abnormalities.
Ingestion: May be toxic. May cause allergic reaction
(hyper-sensitivity) and could result in gastrointestinal
irritation. Large doses may induce kidney injury,
blood disorders, adrenal gland suppression, Cushing's
syndrome, hyper-glycemia, and possibly birth defects
in pregnant mothers.
Inhalation: Not likely for a liquid preparation
because evaporation at controlled room temperature
is minimal. May cause irritation, and repeated or
prolonged inhalation of vapors at high concentration
can induce central nervous system depression
Potential Acute and Chronic Health Effects
indicated by dizziness, headaches, and drowsiness.
Chronic Effects: Hypersensitization is possible in
some individuals. Long term use may cause
ototoxicity.
Target Organs: Kidney, skin and brain.
Medical Conditions Aggravated by Long Term
Exposure: Hypersensitivity to Neomycin Sulfate,
Polymyxin B Sulfate, Hydrocortisone or any of the
components of the product. Anaphylactic cross-
reactions may occur for corticosteroids and
antibiotics including kanamycin, paromomycin,
streptomycin and possibly gentamicin. This
medication is contraindicated for patients with herpes
simplex, vaccinia and varicella infections. As with
other anti-microbial preparations, prolonged use may
result in overgrowth of nonsusceptible organisms
including, fungi. Appropriate measures should be
taken if this occurs. Patients with chronic otitis
medius may develop ototoxicity due to Neomycin.
Hydrocortisone appears in the milk of nursing
mothers when orally administered, so caution should
be exercised when prescribing Neomycin Sulfate,
Polymyxin B Sulfate, Hydrocortisone Otic
Pregnancy Comments
Suspension Non-Buffered. Additional details are
available on the package insert or in the Physicians
Desk Reference.
Paddock Laboratories, Inc. Page 2 of 9
SECTION 4: FIRST AID MEASURES
Remove all contaminated clothing and wash skin
with copious amounts of water for at least 20
Skin Exposure
minutes. Contact physician if skin becomes irritated.
Rinse immediately with copious amounts of water for
Eye Exposure
at least 20 minutes. Contact a physician.
Remove person to fresh air, and if breathing stops,
Inhalation
use artificial respiration. Contact physician.
Wash out mouth and drink plenty of water and bland
fluids. The use of an emetic drug and/or gastric
Ingestion
lavage is advisable. Do not give anything to an
unconscious person. Contact physician.
SECTION 5: FIRE / EXPLOSION HAZARDS & FIREFIGHTING MEASURES
NA
Flammability of the Product
NA
Auto-ignition Temperature
NA
Flash Points
Lower: NA Upper: NA
Flammable Limits (in air by volume, %)
Use extinguishing agent suitable for type of
surrounding fire.
Fire Extinguishing Equipment Water Spray: Will froth if sprayed into burning
material
Foam: OK
Carbon Dioxide: OK
Dry Chemical: OK
Emits toxic fumes; Mercury Vapors (Hg), Sulfur
Unusual Fire and Explosion Hazards Oxides (SOx), Nitrogen Oxides (NOx), Sodium
Oxides (NaOx) when burning
Explosion Hazards in presence of Various
NA
substances
Firefighters should wear full protective gear
including self contained breathing apparatus. Do not
Firefighting Procedures
spray water into burning material.
SECTION 6: SPILL AND LEAK PROCEDURES
Use personal protective equipment. Contain the spill
Spills to prevent drainage into sewers, drains or streams. Use
absorbent material to solidify the spill. Shovel or
Paddock Laboratories, Inc. Page 3 of 9
scoop up solidified waste. Dispose of material
according to Federal, State and Local regulations.
SECTION 7: HANDLING AND STORAGE
Avoid getting this product ON YOU or IN YOU. Do
not eat, drink or smoke or apply cosmetics while
Work and Hygiene Practices
handling the product. Wash hands thoroughly after
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 and Handling Practices
Store product upright in original containers with the
cap tightly closed at a controlled room temperature
15掳-30掳 C (59掳- 86掳 F). KEEP THIS AND ALL
DRUGS OUT OF THE REACH OF CHILDREN.
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
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
Engineering Controls
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.
Personal 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
Respiratory Protection
in oxygen-depleted environments. No
respiratory protection is required in the clinical
or home environment.
Safety glasses or goggles.
Eye Protection
Gloves.
Hand Protection
Lab coat.
Body Protection
Paddock Laboratories, Inc. Page 4 of 9
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES
White to off-white, flowing suspension
Physical state and appearance
NA
Molecular Weight
NA
Boiling Point
NA
Vapor Density (AIR=1)
NA
Vapor Pressure (mm Hg)
NA
Melting/Freezing Point
NA
pH
Miscible
Water Solubility
1.0
Specific Gravity (Water =1)
NA
Water Reactivity
NA
Volatility
NA
Odor
SECTION 10: STABILITY AND REACTIVITY
This product is stable.
Stability
Extreme heat or cold
Incompatible Temperature
This product has no incompatibilities except those of
water e.g. strong acids, bases, alkali metals, alkali
Incompatible Materials
hydrides and silver preparations.
NA
Conditions of Instability
Should not occur
Hazardous Polymerization
Mercury vapor, Sulfur oxides (SOX), nitrogen oxides
(NOX),
Hazardous Decomposition
sodium oxides (NaOX) and emits toxic fumes.
Extreme heat or cold
Conditions to Avoid
Paddock Laboratories, Inc. Page 5 of 9
SECTION 11: TOXICOLOGICAL INFORMATION
36653-82-4 Cetyl Alcohol (Palmityl alcohol)
May cause irritation to eyes, skin, respiratory tract
and gastrointestinal system. Repeated and prolonged
exposure may cause hypersensitivity in some
individuals. Chemical is a normal constituent of the
human body and is considered non-toxic.
Gastrointestinal system irritation symptoms are
hypermotility and diarrhea. Irritation SKN-HMN
75mg/kg mild. Oral-rat LD50 5 gm/kg.
50-23-7 Hydrocortisone
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, water retention, electrolyte imbalance, and
hyper-glycemia. Studies in animals indicate that
topical adrenocorticoids, when used in large amounts,
can be systemically absorbed and may cause fetal
abnormalities. Human pregnancy studies have not
been done. IP-rat LD50 150 mg/kg, SC-rat LD50 449
mg/kg.
Toxicity
1404-04-2 Neomycin Sulfate
Prolonged or repeated contact can cause hyper-
sensitivity (anaphylactic) in some individuals. People
sensitive to one aminoglycoside antibiotic may also
be sensitive to neomycin sulfate. High level
overdosage may be toxic to kidneys (nephrotoxicity)
and may cause hearing difficulties (ototoxicity) and
diminished balance. Oral- rat LD50 2750 mg/kg.
1404-26-8 Polymyxin B Sulfate
May cause irritation to skin, mucous membranes and
respiratory tract. Prolonged and repeated contact can
produce hypersensitivity (anaphylactic) in some
individuals. Overexposure may produce dizziness,
diminished muscular coordination, kidney damage
(nephrotoxicity), and sensory disturbances. This
material is not readily adsorbed into the gut and does
not present a toxicological hazard. IV- mouse LD50
5.4 mg/kg, IP- mouse 20.5 mg/kg, Oral- mouse 790
mg/kg, SC- mouse LD50 59.5 mg/kg.
9004-99-3 Polyoxyl 40 Stearate
Little health hazard. Practically nonirritating to eyes.
Inhalation suggested control figure for good hygiene
10 mg/m3. Oral-rat LD50 > 34.8 g/kg.
Paddock Laboratories, Inc. Page 6 of 9
9005-65-6 Polysorbate 80
Limited toxicity data is available on this chemical.
Screening tests indicate that it is not likely to irritate
the eyes, skin, respiratory or digestive tract. Skin
hypersensitization was not observed in 50 human
subjects tested by patch test. The toxicity by
ingestion is relatively mild. Oral-rat LD50 >38.0
g/kg. No other symptoms of exposure were recorded.
57-55-6 Propylene Glycol
May cause irritation to respiratory tract, digestive
tract, eyes and skin. Prolonged or repeated contact
can produce hypersensitivity (anaphylactic) in some
individuals causing headache, nausea,dullness,
abdominal spasms, vomiting and unconsciousness.
Repeated exposure may also cause nystagmus and
lymphocytosis. High vapor concentration exposure
may cause central nervous system depression with
headaches, dizziness and drowsiness. This material is
adsorbed by inhalation, ingestion, and through the
skin. Kidney injury and blood disorders may occur.
Combustible liquid. Oral- rat LD50- 20 g/kg, Skin-
rabbit LD50- 20800 mg/kg.
54-64-8 Thimerosal
May cause irritation to mucous membranes of lungs
and eyes. Sensitization dermatitis may occur in
persons previously exposed. Chemical burns can
occur and may cause conjunctivitis in cases of
chronic exposure. Contains mercury. Toxic by
ingestion and possibly inhalation. Oral-rat LD50 75
mg/kg.
No
Suspected Cancer Agent
SECTION 12: ECOLOGICAL INFORMATION
Product administered to patients presents a negligible
Environmental Stability
impact on the environment.
NA
Ecotoxicity
The products of degradation are more toxic.
Products of Biodegradation
NA
Special Remarks
SECTION 13: WASTE DISPOSAL
Dispose of material according to local, state, and federal regulations.
SECTION 14: TRANSPORTATION INFORMATION
Paddock Laboratories, Inc. Page 7 of 9
Not a DOT controlled material.
DOT classification
NA
Identification
No
DOT Label(s) Required
SECTION 15: REGULATORY INFORMATION
SECTION 302 Extremely Hazardous Substances:
No Components Listed
SECTION 311, 312 Hazard Categories: NA
US SARA Reporting Requirements
SECTION 313 Toxic Chemicals CAS# 54-64-8:
Mercury compounds are subject to the reporting
requirements of Section 313 of SARA Title III.
EPA Designations: RCRA Hazardous Waste
(40 CFR 261.33) Not Listed
FDA Designations: Prescription only medication.
Federal and State Regulations
NDC No. 0574-4103-10 (10 ml)
OSHA Designations: 29 CFR 1910.1000, Table Z
Mercury compounds listed
NA
U.S. TSCA Inventory Status
SECTION 16: OTHER INFORMATION
DEFINITIONS OF ABBREVATIONS USED:
American Conference of Governmental Industry Hygienists
ACGIH
Chemical Abstract Service
CAS
International Agency for Research on Cancer
IARC
Immediately Dangerous to Life or Health Level
IDLH
Medial Lethal Concentration
LC50
Medial Lethal Dose
LD50
Mine Safety and Health Administration
MSHA
Not Available
NA
No Data
ND
Not Established
NE
National Institute for Occupational Safety and Health
NIOSH
National Toxicology Program
NTP
Occupational Safety and Health Administration
OSHA
Permissible Exposure Limit
PEL
Superfund Amendments and Reauthorization Act
SARA
Short Term Exposure Limit
STEL
Threshold Limit Value
TLV
Time Weighted Average
TWA
Paddock Laboratories, Inc. Page 8 of 9
SECTION 17: DISCLAIMER
The information contained in this Material Safety Data Sheet has been compiled from reliable sources and
is believed to be correct as of the date issued. It is the responsibility of the user to determine the
appropriateness and applicability to their situation. Paddock Laboratories, Inc. disclaims any expressed or
implied warranty as to the accuracy of the above information and shall not be held liable for any direct,
incidental, or consequential damages from use or reliance on the above information.
Paddock Laboratories, Inc. Page 9 of 9
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