Nycomed US Inc.
MATERIAL SAFETY DATA SHEET
Prepared to U.S. OSHA, CMA, ANSI, and Canadian WHMIS
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
TRADE NAME/MATERIAL NAME: Mometasone Furoate Ointment 0.1%
Mometasone Furoate Ointment
DESCRIPTION:
0168-0271-15; 0168-0271-46
NDC #:
9,21-Dichloro-11,17dihydroxy-16-methylpregna-1,4-
CHEMICAL NAME (for active ingredient):
diene-3,20-dione 17-(2-Furoate)
Corticosteroid
CHEMICAL FAMILY (for active ingredient):
0.1% Ointment
HOW SUPPLIED:
C27H30Cl2O6
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: NYCOMED US INC.
60 Baylis Road
ADDRESS:
Melville, NY 11747
1-631-454-7677
BUSINESS PHONE/GENERAL MSDS INFORMATION:
EMERGENCY PHONE (U.S./Canada/Puerto Rico): 1-800-424-9300 (24-hrs)
EMERGENCY PHONE (OUTSIDE U.S.): +1-631-454-7677
NOTE: ALL United States Occupational Safety and Health Administration Standard (29 CFR 1910.1200), U.S. State equivalent Standards, and Canadian WHMIS [Controlled
Products Regulations] required information is included in appropriate sections based on the U.S. ANSI Z400.1-2004 format. This product has been classified in accordance
with the hazard criteria of the countries listed above.
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a white to off-white, ointment with a petroleum jelly
odor. Health Hazards: Employees administering the product should not experience adverse effects if handled
properly. The chief health hazard associated with exposure during normal use and handling is the potential for irritation
of contaminated skin. Individuals who have had allergic reactions to products containing the active ingredient,
Mometasone Furoate (or any other components of this product) may experience allergic reactions to this product.
Repeated skin exposure to Mometasone Furoate may cause adverse reproductive effects, based on animal data.
Flammability Hazards: This product is combustible. When involved in a fire, this material may decompose and
produce irritating vapors and toxic compounds (including carbon oxides and hydrogen chloride). Reactivity Hazards:
This product is not reactive. Environmental Hazards: This product has not been tested for environmental effects.
Emergency Considerations: Emergency responders should wear appropriate protection for situations to which they
respond.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Mometasone Furoate 83919-23-7 0.1%
Propylene Glycol Stearate 1323-39-3 Proprietary
Beeswax (White Wax) 8006-40-4 Proprietary
Hexylene Glycol 107-41-5 Proprietary
White Petrolatum 8009-03-8 Proprietary
Water and other components. Each of the other components is present in less The remaining components do not contribute any significant Balance
additional hazards.
than 1 percent concentration (0.1% concentration for potential carcinogens,
reproductive toxins, respiratory tract sensitizers, and mutagens).
PART II What should I do if a hazardous situation occurs?
4 FIRST-AID MEASURES
Persons developing hypersensitivity reactions should receive medical attention. If breathing is difficult, give oxygen. If
not breathing, give artificial respiration. Take a copy of label and MSDS to physician or health professional with the
contaminated individual.
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 1 OF 10
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions.
INGESTION: If this product is swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT
INFORMATION. If professional advice is not available, do not induce vomiting. Never induce vomiting or give diluents
(milk or water) to someone who is unconscious, having convulsions, or unable to swallow. If victim is convulsing,
maintain an open airway and obtain immediate medical attention.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Pre-existing skin conditions may be aggravated by repeated
overexposures to this product.
RECOMMENDATIONS TO PHYSICIANS: This product should only be given to patients by persons experienced in
management of patients receiving the type of therapy intended for this product. Treat symptoms and eliminate
exposure.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not established.
NFPA RATING
AUTOIGNITION TEMPERATURE: Not established.
FLAMMABLE LIMITS (in air by volume, %): FLAM MAB ILITY
Lower (LEL): Not applicable.
Upper (UEL): Not applicable.
1
Use extinguishing media
FIRE EXTINGUISHING MATERIALS:
appropriate for surrounding fire. 1 0
HEALTH INSTAB ILITY
Water Spray: OK Carbon Dioxide: OK
Foam: OK Dry Chemical: OK
Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
OTHER
This product is
UNUSUAL FIRE AND EXPLOSION HAZARDS:
combustible. When involved in a fire, this material may decompose and Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe
produce irritating vapors and toxic compounds (including carbon oxides
and hydrogen chloride).
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye protection. Structural
firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. If protective
equipment is contaminated by this product, it should be thoroughly washed with running water prior to removal of
SCBA respiratory protection. Firefighters whose protective equipment becomes contaminated should thoroughly
shower with warm, soapy water and should receive medical evaluation if they experience any adverse effects.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: Proper protective equipment should be used. In the event of a spill, clear the area
and protect people. The atmosphere must have levels of components lower than those listed in Section 8, (Exposure
Controls and Personal Protective Equipment) if applicable, and have at least 19.5 percent oxygen before personnel can
be allowed into the area without Self-Contained Breathing Apparatus (SCBA).
Small Spills: Wear goggles and gloves while wiping up small spills of this product with polypad or sponge.
Large Spills: Trained personnel following pre-planned procedures should handle non-incidental releases. Access to the spill
areas should be restricted. Protective apparel should be used with a respirator when there is any danger of mists or sprays
being generated. Minimum Personal Protective Equipment should be rubber gloves, rubber boots, face shield, and Tyvek suit.
The dispersal of mists or sprays into surrounding air and the possibility of inhalation is a serious matter and should be treated as
such. Minimum level of personal protective equipment for releases in which the level of oxygen is less than 19.5% or is
unknown must be Level B: triple-gloves (rubber gloves and nitrile gloves over latex gloves), chemical resistant suit and
boots, hard hat, and Self-Contained Breathing Apparatus. Absorb spilled liquid using polypads or other suitable absorbent
material. Prevent material from entering sewer or confined spaces, waterways, soil or public waters. Monitor area and confirm
levels are bellow exposure limits given in Section 8 (Exposure Controls-Personal Protection), if applicable, before non-response
personnel are allowed into the spill area.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 2 OF 10
Nycomed US Inc.
6. ACCIDENTAL RELEASE MEASURES (Continued)
SPILL AND LEAK RESPONSE (continued): Decontaminate the area of the spill thoroughly using detergent and
water. Place all spill residue in an appropriate container and seal. Dispose of in accordance with applicable Federal,
State, and local procedures (see Section 13, Disposal Considerations).
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and USE
WORK PRACTICES AND HYGIENE PRACTICES: As with all chemicals, avoid getting this product ON YOU or IN
YOU. Do not eat, drink, smoke, or apply cosmetics while handling this product. Wash hands thoroughly after
handling this product or equipment and containers that contain this product. Follow SPECIFIC USE INSTRUCTIONS
supplied with this product. Particular care in working with this product must be practiced in pharmacies and other
preparation areas, during manufacture of this product, and during patient administration.
STORAGE AND HANDLING PRACTICES: Employees must be trained to properly use this product. Use of this
product should be performed in a designated area for working with drugs. Ensure product is properly labeled. Store
this product away from incompatible materials. Store this product in original container.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
SPECIFIC USE(S): This product is a human pharmaceutical. Follow all industry standards for use of this product.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or butyl rubber (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. Wipe equipment down with damp sponge or polypad. Collect all rinsates and dispose
of according to applicable U.S. Federal, State, and local hazardous waste disposal regulations or waste disposal
regulations of Canada. All disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. During decontamination of work surfaces, workers should wear the same equipment
recommended in Section 6 (Accidental Release Measures) of this MSDS.
EXPOSURE LIMITS/GUIDELINES:
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
Mometasone Furoate 83919-23-7 NE NE NE NE NE NE NE NE
Propylene Glycol Stearate 1323-39-3 10 NE NE NE NE NE NE NE
(Exposure limits are for Stearates)
Beeswax (White Wax) 8006-40-4 NE NE NE NE NE NE NE NE
Hexylene Glycol 107-41-5 NE 121 NE NE NE 125 NE DFG MAK:
ceiling ceiling TWA = 49
PEAK = 2?MAK 15 min,
average value, 1-hr
interval, 4-per shift
White Petrolatum 8009-03-8 NE NE NE NE NE NE NE NE
NE = Not Established. See Section 16 for Definitions of Terms Used.
The following information on appropriate Personal Protective Equipment is provided to assist employers in complying with OSHA
regulations found in 29 CFR Subpart I (beginning at 1910.132) or equivalent standards of Canada (including CSA Standard Z94.4-
02 and CSA Standard Z94.3-07). Please reference applicable regulations and standards for relevant details.
RESPIRATORY PROTECTION: A respirator is not required for routine conditions of use of this product. If respiratory
protection is needed, use only respiratory protection authorized in the U.S. Federal OSHA Respiratory Protection
Standard (29 CFR 1910.134), equivalent U.S. State standards, or Canadian CSA Standard Z94.4-02. Oxygen levels
below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-facepiece pressure/demand SCBA or
a full facepiece, supplied air respirator with auxiliary self-contained air supply is required under OSHA's Respiratory
Protection Standard (1910.134-1998).
EYE PROTECTION: Not normally needed during normal use. If necessary, refer to U.S. OSHA 29 CFR 1910.133 or
Canadian CSA Standard Z94.3-07.
HAND PROTECTION: For situations in which prolonged skin contact is anticipated, double glove, using latex, nitrile,
or rubber gloves. Check gloves for leaks. Wash hands before putting on gloves and after removing gloves. Gloves
should cover the gown cuff. If necessary, refer to U.S. OSHA 29 CFR 1910.138 or appropriate standards of Canada.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 3 OF 10
Nycomed US Inc.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
BODY PROTECTION: During patient administration, use of lightweight cotton gown or other medical attire is
recommended. If a hazard of injury to the feet exists due to falling objects, rolling objects, where objects may pierce the
soles of the feet or where employee's feet may be exposed to electrical hazards, use foot protection, as described in
U.S. OSHA 29 CFR 1910.136 and the Canadian CSA Standard Z195-02, Protective Footwear.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: Not established. FREEZING/MELTING POINT: Not established.
EVAPORATION RATE (nBuAc = 1): Not established. SOLUBILITY IN WATER: Insoluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 60癈 (water = 1): 0.85?.90
ODOR THRESHOLD: Not established. pH: Not established.
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a white to off-white, ointment with a petroleum jelly odor.
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance of this product can be a distinguishing
characteristic to identify it in event of accidental release.
10. STABILITY and REACTIVITY
STABILITY: This product is stable.
DECOMPOSITION PRODUCTS: If exposed to extremely high temperatures, thermal decomposition may generate
irritating fumes and toxic gases (e.g., carbon oxides and hydrogen chloride).
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other
common materials in a medical facility. Acids, caustics, and other chemicals that could affect its performance should
be avoided.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid heat, light, and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The
health hazard information provided below is pertinent to medical employees HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
handling this product in an occupational setting. This product is designed for
application on the skin. The following paragraphs describe the symptoms of (BLUE) 1
HEALTH HAZARD
exposure by route of exposure.
INHALATION: Although unlikely due to form of product, inhalation of
vapors of this product may slightly irritate the nose, throat, and lungs.
Symptoms are generally alleviated upon breathing fresh air. FLAMMABILITY HAZARD (RED) 1
CONTACT WITH SKIN or EYES: Skin contact may cause burning
sensation, stinging, prickling, itching, and tingling. Corticosteroids (such
as Mometasone Furoate) may cause allergic contact dermatitis. This is
PHYSICAL HAZARD (YELLOW) 0
usually diagnosed by observing a failure to heal rather than a clinical
exacerbation. Eye contact can cause irritation, stinging, redness, and
tearing.
SKIN ABSORPTION: The Mometasone Furoate component of this product PROTECTIVE EQUIPMENT
can be absorbed through intact skin. Symptoms of chronic overexposure
by this route may include reversible hypothalamic-pituitaryadrenal (HPA) EYES HANDS BODY
RESPIRATORY
axis suppression, abnormal accumulations of facial and trunk fat, fatigue,
high blood pressure, osteoporosis, abnormally high level of glucose in the SEE SECTION 8 SEE SECTION 8
blood, and abnormally high levels of glucose in the urine.
INGESTION: Ingestion is not a significant route of occupational For Routine Industrial Use and Handling Applications
overexposure. Acute ingestion of large quantities of this product or chronic
ingestion caused by poor hygiene practices may cause adverse Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe * = Chronic hazard
symptoms. Symptoms of ingestion overexposure may include nausea,
vomiting, and diarrhea.
INJECTION: Though not anticipated to be a significant route of exposure for this product, injection (via punctures or
lacerations by contaminated objects) may cause redness at the site of injection. Symptoms may include those
described for "General Toxicity Information".
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 4 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the
Mometasone Furoate component of this product or any other components of this product may experience allergic
reactions to this product. Symptoms described in patients given therapeutic doses of this substance include the
following.
For Males and Females: Persons using the product in therapeutic doses may experience acne-like reaction;
inflammation of hair follicles; decreased glucocortoid levels; burning, prickling, itching, or tingling of the skin; dry
mouth; unspecified endocrine disorder; skin shininess, raised dark red blotches on the skin; loss of skin elasticity, and
loss of normal skin markings.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Corticosteroids (such as Mometasone Furoate) may cause allergic contact
dermatitis.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms. Overexposure to this product may
cause the following health effects:
Acute: The primary health effects that may be experienced by medical personnel exposed to this product is mild
irritation of contaminated skin. Accidental ingestion may be harmful. Although unlikely, inhalation can irritate the
respiratory system. Eye contact will cause irritation.
Chronic: Corticosteroids (such as Mometasone Furoate) may cause allergic contact dermatitis. Symptoms of chronic
skin absorption exposure may include reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, abnormal
accumulations of facial and trunk fat, fatigue, high blood pressure, osteoporosis, abnormally high level of glucose in
the blood, and abnormally high levels of glucose in the urine.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, eyes. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin, endocrine system.
TOXICITY DATA: The toxicity data available for the active component of this product, Mometasone Furoate, are
presented in this MSDS. Additional data are available for the excipient components of this product, but are not
presented in this MSDS; Contact Nycomed US Inc. for more information.
MOMETASONE FUROATE: MOMETASONE FUROATE (continued): MOMETASONE FUROATE (continued):
LD50 (Subcutaneous-Rat) 300 mg/kg: Respiration: TDLo (Subcutaneous-Rat) 210 礸/kg: female 14 TDLo (Subcutaneous-Rat) 13 mg/kg: female 6-18
respiratory depression; Nutritional and Gross days pre-mating: 7 days after conception: days after conception: Reproductive: Effects on
Metabolic: body temperature decrease Reproductive: Fertility: post-implantation mortality Embryo or Fetus: fetotoxicity (except death, e.g.,
LDLo (Subcutaneous-Mouse) 1 g/kg (e.g. dead and/or resorbed implants per total stunted fetus), other effects to embryo; Specific
TDLo (Skin-Rat) 10,920 礸/kg/52 weeks-continuous: number of implants); Effects on Fetus: fetotoxicity Developmental Abnormalities: craniofacial
Lungs, Thorax, or Respiration: other changes; (except death, e.g., stunted fetus), fetal death (including nose and tongue)
Endocrine: adrenal cortex hypoplasia; Blood: TDLo (Subcutaneous-Rat) 330 礸/kg: female 7-17 TDLo (Skin-Rabbit) 2600 礸/kg: female 6-18 days
changes in spleen days after conception: Effects on Newborn: after conception: Reproductive: Musculoskeletal
TDLo (Skin-Dog) 36,400 礸/kg/52 weeks- growth statistics (e.g.%, reduced weight gain), Developmental Abnormalities
continuous: Liver: other changes; Endocrine: physical TDLo (Skin-Rabbit) 13 mg/kg: female 6-18 days
adrenal cortex hypoplasia; Blood: other changes TDLo (Subcutaneous-Rat) 13 礸/kg: female 7-17 after conception: Reproductive: Specific
TDLo (Subcutaneous-Rat) 66 礸/kg: female 7-17 days after conception: Reproductive: Effects on Developmental Abnormalities: cardiovascular
days after conception: Reproductive: Effects on Newborn: behavioral (circulatory) system Reproductive: Specific
Fetus: fetotoxicity (except death, e.g., stunted Developmental Abnormalities: cardiovascular
fetus); Musculoskeletal Developmental (circulatory) system
Abnormalities
CARCINOGENIC INFORMATION: The following information is available from carcinogenic studies performed with the
active ingredient of this product, Mometasone Furoate:
Long-term carcinogenicity studies of Mometasone Furoate were conducted by the inhalation route in rats and mice.
In a 2-year carcinogenicity study in Sprague-Dawley rats, Mometasone Furoate demonstrated no statistically
significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated
maximum clinical topical dose from Mometasone Furoate Ointment 0.1% on a mcg/m2 basis). In a 19-month
carcinogenicity study in Swiss CD-1 mice, Mometasone Furoate demonstrated no statistically significant increase
in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum
clinical topical dose from Mometasone Furoate Ointment 0.1% on a mcg/m2 basis).
The incipient components of this product are listed by agencies tracking the carcinogenic potential of chemical
compounds, as follows:
PROPYLENE GLYCOL STEARATE (as a stearate compound): ACGIH TLV-A4 (Not Classifiable as Human Carcinogen)
The remaining components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S.
NIOSH, GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer-
causing agents by these agencies.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 5 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION: The active component of this product, Mometasone Furoate, is rated as
Pregnancy Category C (RISK CANNOT BE RULED OUT; Human evidence is lacking, but animal evidence is
positive). Listed below is information concerning the effects of this product and its components on animal or human
reproductive systems.
Mutagenicity: Mometasone Furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did
no increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone Furoate was not mutagenic
in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone
marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone Furoate also
did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
Embryotoxicity: This product has not been tested for embryotoxic effects.
Teratogenicity: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory
animals. When administered to pregnant rats, rabbits, and mice, Mometasone Furoate increased fetal malformations. The
doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed
ossification. Mometasone Furoate also caused dystocia and related complications when administered to rats during the end of
pregnancy. In mice, Mometasone Furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival
was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are
approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment
2
0.1% on a mcg/m basis). In rats, Mometasone Furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are
approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment 0.1% on a
mcg/m2 basis). In rabbits, Mometasone Furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis,
umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum
2
clinical topical dose from Mometasone Furoate Ointment 0.1% on a mcg/m basis). In an oral study, Mometasone Furoate
increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At
2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800
mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from Mometasone
2
Furoate Ointment 0.1% on a mcg/m basis). When rats received subcutaneous doses of Mometasone Furoate throughout
pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of
live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in
the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from Mometasone Furoate
2
Ointment 0.1% on a mcg/m basis).
Reproductive Toxicity: In reproductive studies in rats, impairment of fertility was not produced in male or female rats by
subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from
Mometasone Furoate Ointment 0.1% on a mcg/m2 basis).
A mutagen is a chemical that causes permanent changes to genetic material (DNA) such that the changes will propagate through generation lines. An
embryo toxin is a chemical that causes damage to a developing embryo (i.e. within the first eight weeks of pregnancy in humans), but the damage
does not propagate across generational lines. A teratogen is a chemical that causes damage to a developing fetus, but the damage does not
propagate across generational lines. A reproductive toxin is any substance that interferes in any way with the reproductive process.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently, there are no ACGIH Biological Exposure Indices (BEIs)
determined for components of this product.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: The components of this product will slowly degrade in the environment and form a
variety of organic materials. The following environmental data are available for the components of this product:
HEXYLENE GLYCOL:
Terrestrial Fate: A variety of biological screening studies have demonstrated that Hexylene Glycol readily biodegrades; therefore, biodegradation is expected to be the
dominant degradation process in soil. Since Hexylene Glycol is miscible in water, it is likely to leach readily in soil; its detection in landfill leachates indicates that it
will leach in the environment; however, its ability to biodegrade readily should lessen the importance of leaching.
Aquatic Fate: A variety of biological screening studies have demonstrated that Hexylene Glycol readily biodegrades; therefore, biodegradation is expected to be the
dominant degradation process in natural water. Aquatic volatilization, bioconcentration, hydrolysis, and adsorption to sediment are not expected to be important fate
processes.
Atmospheric Fate: Based upon a vapor pressure of 0.013 mm Hg at 25癈, 2 Hexylene Glycol is expected to exist almost entirely in the vapor phase in the ambient
atmosphere. Hexylene Glycol will degrade in the ambient atmosphere by reaction with photochemically produced hydroxyl radicals with an estimated half-life of
about 1.6 days. Hexylene Glycol is miscible in water, therefore, physical removal from air through wet deposition (rainfall, dissolution into clouds, washout, etc) is
possible.
Bioconcentration: Hexylene Glycol is miscible in water; therefore, bioconcentration in aquatic organisms in not expected to be an important fate process.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of this
product on plants or animals in the environment. This product may be harmful to contaminated plant and animal life,
especially in large quantities.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 6 OF 10
Nycomed US Inc.
12. ECOLOGICAL INFORMATION (Continued)
EFFECT OF CHEMICAL ON AQUATIC LIFE: Release of this product to an aquatic environment may be harmful to
aquatic plant and animal life in contaminated bodies of water, especially in large quantities. The following aquatic
toxicity data are available for the components of this product:
HEXYLENE GLYCOL: HEXYLENE GLYCOL (continued):
LD50 (goldfish) 24 hours = > 5,000 mg/L LC50 (Pimephales promelas fathead minnow) 96 hours = 10,700 mg/L, flow-
LC0,S (Lepomis macrochirus) 24-96 hours = > 10,000 ppm through bioassay, wt 0.12 g, water hardness 45.5 mg/L CaCO3, temp: 25 ?br>
LC50 (Menidia beryllina) static bioassay in synthetic seawater at 23癈, mild 1癈, pH 7.5, dissolved oxygen greater than 60% of saturation
aeration applied after 24 hr: % survival after material added
13. DISPOSAL CONSIDERATIONS
DISPOSAL METHODS: It is the responsibility of the generator to determine at the time of disposal whether the product
meets the criteria of a hazardous waste per regulations of the area in which the waste is generated and/or disposed of.
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered
by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory
authority. Shipment of wastes must be done with appropriately permitted and registered transporters.
DISPOSAL CONTAINERS: Waste materials must be placed in and shipped in appropriate 5-gallon or 55-gallon poly or
metal waste pails or drums. Permeable cardboard containers are not appropriate and should not be used. Ensure that
any required marking or labeling of the containers be done to all applicable regulations.
PRECAUTIONS TO BE FOLLOWED DURING WASTE HANDLING: Wear proper protective equipment when handling
waste materials.
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State,
and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by
treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves,
and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with
established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents. Incineration
is recommended. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of this product.
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is not classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is not
classified as Dangerous Goods, per regulations of Transport Canada.
15. REGULATORY INFORMATION
UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are not subject to the reporting
requirements of Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act.
U.S. SARA THRESHOLD PLANNING QUANTITY: There are no specific Threshold Planning Quantities for any
component of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000
lb (4,540 kg) therefore applies, per 40 CFR 370.20.
U.S. CERCLA REPORTABLE QUANTITIES (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: This product is regulated by the Food and Drug Administration; it is not subject to
requirements under TSCA.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): The components
of this product are not on the California Proposition 65 lists.
OTHER U.S. FEDERAL REGULATIONS: Not applicable.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): WARNING! MAY
CAUSE ALLERGIC SKIN REACTION. MAY CAUSE SKIN AND EYE IRRITATION. Avoid prolonged or repeated
contact with skin and clothing. Avoid contact with eyes. Wash thoroughly after handling. Wear gloves, safety glasses,
and appropriate body protection during handling or administration. FIRST-AID: In case of contact, flush skin or eyes
with plenty of water. If adverse respiratory reaction occurs, give oxygen and seek immediate medical attention. If
ingested, DO NOT induce vomiting-seek immediate medical attention. IN CASE OF FIRE: Use water fog, dry
chemical, CO2, or "alcohol" foam. IN CASE OF SPILL: Wipe up spilled product. Place residual in appropriate
container and seal. Dispose of according to applicable regulations. Consult Material Safety Data Sheet for additional
information.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 7 OF 10
Nycomed US Inc.
15. REGULATORY INFORMATION (Continued)
CANADIAN REGULATIONS:
CANADIAN DSL/NDSL INVENTORY STATUS: This product regulated by the Therapeutic Products Programme (TPP)
of Health Canada and so it is exempt from requirements of the DSL/NDSL Inventory.
CANADIAN ENVIRONMENTAL PROTECTION ACT (CEPA) PRIORITIES SUBSTANCES LISTS: The components of
this product are not on the CEPA Priorities Substances Lists.
OTHER CANADIAN REGULATIONS: Not applicable.
CANADIAN WHMIS CLASSIFICATION AND SYMBOLS: Not applicable.
16. OTHER INFORMATION
This Material Safety Data Sheet is offered pursuant to OSHA's Hazard Communication Standard, 29 CFR, 1910.1200. Other government regulations must be reviewed
for applicability to this product. To the best of Nycomed US Inc.'s knowledge, the information contained herein is reliable and accurate as of this date; however,
accuracy, suitability or completeness are not guaranteed and no warranties of any type, either express or implied, are provided. The information contained herein
relates only to this specific product. If this product is combined with other materials, all component properties must be considered. Data may be changed from time to
time. Be sure to consult the latest edition.
CHEMICAL SAFETY ASSOCIATES, Inc.
PREPARED BY:
PO Box 3519, La Mesa, CA 91944-3519
800/441-3365 ?619/670-0609
May 14, 2009
DATE OF PRINTING:
DEFINITION OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely identifies EXPOSURE LIMITS IN AIR (continued):
each constituent. PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly
the same as a TLV, except that it is enforceable by OSHA. The OSHA
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air
the working exposure. Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have current PELs and the vacated PELs are indicated. The phrase, "Vacated 1989
been shown to increase the mutant frequency in the progeny of exposed humans. PEL" is placed next to the PEL that was vacated by Court Order.
2: Germ cell mutagens that have been shown to increase the mutant frequency in SKIN: Used when a there is a danger of cutaneous absorption.
the progeny of exposed mammals. 3A: Substances that have been shown to STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average
induce genetic damage in germ cells of human of animals, or which produce (TWA) exposure that should not be exceeded at any time during a workday, even
mutagenic effects in somatic cells of mammals in vivo and have been shown to if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA.
reach the germ cells in an active form. 3B: Substances that are suspected of TLV: Threshold Limit Value. An airborne concentration of a substance that
being germ cell mutagens because of their genotoxic effects in mammalian represents conditions under which it is generally believed that nearly all workers
somatic cell in vivo; in exceptional cases, substances for which there are no in may be repeatedly exposed without adverse effect. The duration must be
vivo data, but that are clearly mutagenic in vitro and structurally related to known considered, including the 8-hour.
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are TWA: Time Weighted Average exposure concentration for a conventional 8-hr
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens (TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At WEEL: Workplace Environmental Exposure Limits from the AIHA.
some time in the future, it is conceivable that a Category 4 could be established HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
for genotoxic substances with primary targets other than DNA [e.g. purely RATINGS: This rating system was developed by the National Paint and Coating
aneugenic substances] if research results make this seem sensible.) 5: Germ cell Association and has been adopted by industry to identify the degree of chemical
mutagens, the potency of which is considered to be so low that, provided the MAK hazards.
value is observed, their contribution to genetic risk for humans is expected not to HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
be significant. eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
the developing embryo or fetus has been unequivocally demonstrated. Exposure effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
of pregnant women can lead to damage of the developing organism, even when Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
MAK and BAT (Biological Tolerance Value for Working Materials) values are mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1) Slight Hazard: Minor
observed. Group B: Currently available information indicates a risk of damage to reversible injury may occur; may irritate the stomach if swallowed; may defat the
the developing embryo or fetus must be considered to be probable. Damage to skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
the developing organism cannot be excluded when pregnant women are exposed, PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
even when MAK and BAT values are observed. Group C: There is no reason to 7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal
fear a risk of damage to the developing embryo or fetus when MAK and BAT Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
values are observed. Group D: Classification in one of the groups A瑿 is not yet Rat: > 2?0 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
possible because, although the data available may indicate a trend, they are not prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating;
sufficient for final evaluation. primary irritant; sensitizer. PII or Draize 5, with no destruction of dermal tissue.
IDLH: Immediately Dangerous to Life and Health. This level represents a Eye Irritation: Moderately to severely irritating; reversible corneal opacity; corneal
concentration from which one can escape within 30-minutes without suffering involvement or irritation clearing in 8?1 days. Draize = 26?00, with reversible
escape-preventing or permanent injury. effects. Oral Toxicity LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or
LOQ: Limit of Quantitation. Rabbit: > 200?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3
MAK: Federal Republic of Germany Maximum Concentration Values in the Serious Hazard: Major injury likely unless prompt action is taken and medical
workplace. treatment is given; high level of toxicity; corrosive. Skin Irritation: Severely irritating
NE: Not Established. When no exposure guidelines are established, an entry of and/or corrosive; may cause destruction of dermal tissue, skin burns, and dermal
NE is made for reference. necrosis. PII or Draize > 5?, with destruction of tissue. Eye Irritation: Corrosive,
NIC: Notice of Intended Change. irreversible destruction of ocular tissue; corneal involvement or irritation persisting
NIOSH CEILING: The exposure that shall not be exceeded during any part of the for more than 21 days. Draize > 80 with effects irreversible in 21 days. Oral
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed Toxicity LD50 Rat: > 1?0 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20?00
as a 15-minute TWA exposure (unless otherwise specified) that shall not be mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe Hazard: Life-
exceeded at any time during a workday. threatening; major or permanent damage may result from single or repeated
NIOSH RELs: NIOSH's Recommended Exposure Limits. exposures; extremely toxic; irreversible injury may result from brief contact. Skin
Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral
Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 8 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
RATINGS (continued): RATINGS (continued):
FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air PHYSICAL HAZARD (continued): 3 Water Reactivity: Materials that may form
when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 explosive reactions with water. Organic Peroxides: Materials that are capable of
Slight Hazard: Materials that must be pre-heated before ignition can occur. detonation or explosive reaction, but require a strong initiating source or must be
Material requires considerable pre-heating, under all ambient temperature heated under confinement before initiation; or materials that react explosively with
conditions before ignition and combustion can occur. This usually includes the water. Explosives: Division 1.3 explosives. Explosive substances that have a fire
following: Materials that will burn in air when exposed to a temperature of 815.5癈 hazard and either a minor blast hazard or a minor projection hazard or both, but
(1500癋) for a period of 5 minutes or less; Liquids, solids and semisolids having a do not have a mass explosion hazard. Compressed Gases: Pressure 514.7 psi
flash point at or above 93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing
combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that Group I oxidizers. Solids: any material that, in either concentration tested, exhibits
must be moderately heated or exposed to relatively high ambient temperatures a mean burning time less than the mean burning time of a 3:2 potassium
before ignition can occur. Materials in this degree would not, under normal bromate/cellulose mixture. Liquids: any material that spontaneously ignites when
conditions, form hazardous atmospheres in air, but under high ambient mixed with cellulose in a 1:1 ratio, or which exhibits a mean pressure rise time
temperatures or moderate heating may release vapor in sufficient quantities to less than the pressure rise time of a 1:1 perchloric acid (50%)/cellulose mixture.
produce hazardous atmospheres with air. This usually includes the following: Unstable Reactives: Substances that may polymerize, decompose, condense, or
Liquids having a flash-point at or above 37.8癈 (100癋); Solid materials in the form self-react at ambient temperature and/or pressure and have a moderate potential
of course dusts that may burn rapidly but that generally do not form explosive (or moderate risk) to cause significant heat generation or explosion. 4 Water
atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly Reactivity: Materials that react explosively with water without requiring heat or
and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids confinement. Organic Peroxides: Materials that are readily capable of detonation
(e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. 3 or explosive decomposition at normal temperature and pressures. Explosives:
Serious Hazard: Liquids and solids that can be ignited under almost all ambient Division 1.1 & 1.2 explosives. Explosive substances that have a mass explosion
temperature conditions. Materials in this degree produce hazardous atmospheres hazard or have a projection hazard. A mass explosion is one that affects almost
with air under almost all ambient temperatures, or, unaffected by ambient the entire load instantaneously. Compressed Gases: No Rating. Pyrophorics: Add
temperature, are readily ignited under almost all conditions. This usually includes to the definition of Flammability 4. Oxidizers: No 4 rating. Unstable Reactives:
the following: Liquids having a flash point below 22.8癈 (73癋) and having a Substances that may polymerize, decompose, condense, or self-react at ambient
boiling point at or above 38癈 (100癋) and those liquids having a flash point at or temperature and/or pressure and have a high potential (or high risk) to cause
above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC); significant heat generation or explosion.
Materials that on account of their physical form or environmental conditions can NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
form explosive mixtures with air and are readily dispersed in air (e.g., dusts of HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
combustible solids, mists or droplets of flammable liquids); and Materials that burn hazard beyond that of ordinary combustible materials. Gases and vapors with an
extremely rapidly, usually by reason of self-contained oxygen (e.g. dry LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
rapidly or completely vaporize at atmospheric pressure and normal ambient acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
temperature or that are readily dispersed in air, and that will burn readily. This oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
usually includes the following: Flammable gases; Flammable cryogenic materials; respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
Any liquid or gaseous material that is liquid while under pressure and has a flash can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
point below 22.8癈 (73癋) and a boiling point below 37.8癈 (100癋) (i.e. OSHA toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
Class IA); and Materials that ignite spontaneously when exposed to air at a mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
temperature of 54.4癈 (130癋) or below (pyrophoric). or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
Organic Peroxides: Materials that are normally stable, even under fire conditions moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
and will not react with water. Explosives: Substances that are Non-Explosive. acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. Materials that, under emergency conditions, can cause temporary incapacitation
Unstable Reactives: Substances that will not polymerize, decompose, condense, or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
or self-react.). 1 Water Reactivity: Materials that change or decompose upon 3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
exposure to moisture. Organic Peroxides: Materials that are normally stable, but concentration at 20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute
can become unstable at high temperatures and pressures. These materials may inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
react with water, but will not release energy violently. Explosives: Division 1.5 & meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
1.6 explosives. Substances that are very insensitive explosives or that do not have mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition. equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
material that in either concentration tested, exhibits a mean burning time less than boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture damage, depending on duration of exposure. Materials that are respiratory
and the criteria for Packing Group I and II are not met. Liquids: any material that irritants. Materials that cause severe, but reversible irritation to the eyes or are
exhibits a mean pressure rise time less than or equal to the pressure rise time of a lachrymators. Materials that are primary skin irritants or sensitizers. Materials
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
are not met. Unstable Reactives: Substances that may decompose condense, or to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
self-react, but only under conditions of high temperature and/or pressure and have permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
little or no potential to cause significant heat generation or explosion hazard. 1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
Substances that readily undergo hazardous polymerization in the absence of concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation
inhibitors. Substances that readily undergo hazardous polymerization in the toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
absence of inhibitors. 2 Water Reactivity: Materials that may react violently with criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
water. Organic Peroxides: Materials that, in themselves, are normally unstable toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
and will readily undergo violent chemical change, but will not detonate. These LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
materials may also react violently with water. Explosives: Division 1.4 explosives. mg/kg. Materials that are corrosive to the respiratory tract. Materials that are
Explosive substances where the explosive effects are largely confined to the corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to
package and no projection of fragments of appreciable size or range are the skin. Cryogenic gases that cause frostbite and irreversible tissue damage.
expected. An external fire must not cause virtually instantaneous explosion of Compressed liquefied gases with boiling points below -55癈 (-66.5癋) that cause
almost the entire contents of the package. Compressed Gases: Pressurized and frostbite and irreversible tissue damage. Materials with an LD50 for acute oral
meet OSHA definition but < 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that,
Pyrophorics: No Rating. Oxidizers: Packing Group II oxidizers. Solids: any under emergency conditions, can be lethal. Gases with an LC50 for acute
material that, either in concentration tested, exhibits a mean burning time of less inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose saturated
than or equal to the mean burning time of a 2:3 potassium bromate/cellulose vapor concentration at 20癈 (68癋) is equal to or greater than ten times its LC50 for
mixture and the criteria for Packing Group I are not met. Liquids: any material that acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and
exhibits a mean pressure rise time less than or equal to the pressure rise of a 1:1 mists whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L.
aqueous sodium chlorate solution (40%)/cellulose mixture and the criteria for Materials whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg.
Packing Group I are not met. Reactives: Substances that may polymerize, Materials whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg.
decompose, condense, or self-react at ambient temperature and/or pressure, but
have a low potential (or low risk) for significant heat generation or explosion.
Substances that readily form peroxides upon exposure to air or oxygen at room
temperature.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
PAGE 9 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
(continued): (continued):
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire INSTABILITY HAZARD (continued): 2 Materials that readily undergo violent
conditions, including intrinsically noncombustible materials such as concrete, chemical change at elevated temperatures and pressures. Materials that have an
stone, and sand. Materials that will not burn in air when exposed to a temperature instantaneous power density (product of heat of reaction and reaction rate) at
of 816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA 250癈 (482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in
704. 1 Materials that must be preheated before ignition can occur. Materials in this themselves are capable of detonation or explosive decomposition or explosive
degree require considerable preheating, under all ambient temperature conditions, reaction, but that require a strong initiating source or that must be heated under
before ignition and combustion can occur: Materials that will burn in air when confinement before initiation. Materials that have an estimated instantaneous
exposed to a temperature of 816癈 (1500癋) for a period of 5 minutes in according power density (product of heat of reaction and reaction rate) at 250癈 (482癋) at
with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at or above 100 W/mL and below 1000 W/mL. Materials that are sensitive to thermal
or above 93.4癈 (200癋) (i.e. Class IIIB liquids). Liquids with a flash point greater or mechanical shock at elevated temperatures and pressures. 4 Materials that in
than 35癈 (95癋) that do not sustain combustion when tested using the Method of themselves are readily capable of detonation or explosive decomposition or
Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN explosive reaction at normal temperatures and pressures. Materials that are
sensitive to localized thermal or mechanical shock at normal temperatures and
Recommendations on the Transport of Dangerous Goods, Model Regulations
(current edition) and the related Manual of Tests and Criteria (current edition). pressures. Materials that have an estimated instantaneous power density (product
Liquids with a flash point greater than 35癈 (95癋) in a water-miscible solution or of heat of reaction and reaction rate) at 250癈 (482癋) of 1000 W/mL or greater.
dispersion with a water non-combustible liquid/solid content of more than 85% by FLAMMABILITY LIMITS IN AIR:
weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test Much of the information related to fire and explosion is derived from the National
Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
of the liquid or up to a temperature at which the sample being tested shows an liquid gives off sufficient vapor to form an ignitable mixture with air near the
obvious physical change. Combustible pellets with a representative diameter of surface of the liquid or within the test vessel used. Autoignition Temperature:
greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids Minimum temperature of a solid, liquid, or gas required to initiate or cause self-
containing greater than 0.5% by weight of a flammable or combustible solvent are sustained combustion in air with no other source of ignition. LEL: Lowest
rated by the closed cup flash point of the solvent. 2 Materials that must be concentration of a flammable vapor or gas/air mixture that will ignite and burn with
moderately heated or exposed to relatively high ambient temperatures before a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that
ignition can occur. Materials in this degree would not under normal conditions form will ignite and burn with a flame.
hazardous atmospheres with air, but under high ambient temperatures or under TOXICOLOGICAL INFORMATION:
moderate heating could release vapor in sufficient quantities to produce Human and Animal Toxicology: Possible health hazards as derived from human
hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈 data, animal studies, or from the results of studies with similar compounds are
(100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
materials in the form of powders or coarse dusts of representative diameter animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that ppm: Concentration expressed in parts of material per million parts of air or water.
generally do not form explosive mixtures with air. Solid materials in fibrous or mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
shredded form that burn rapidly and create flash fire hazards, such as cotton, Quantity of material, by weight, administered to a test subject, based on their body
sisal, and hemp. Solids and semisolids that readily give off flammable vapors. weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
Solids containing greater than 0.5% by weight of a flammable or combustible concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids LCo: Lowest dose (or concentration) to cause lethal or toxic effects.
that can be ignited under almost all ambient temperature conditions. Materials in Cancer Information: IARC: International Agency for Research on Cancer. NTP:
this degree produce hazardous atmospheres with air under almost all ambient National Toxicology Program. RTECS: Registry of Toxic Effects of Chemical
temperatures or, though unaffected by ambient temperatures, are readily ignited Substances. IARC and NTP rate chemicals on a scale of decreasing potential to
under almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and cause human cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are
having a boiling point at or above 37.8癈 (100癋) and those liquids having a flash also used. Other Information: BEI: ACGIH Biological Exposure Indices, represent
point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC the levels of determinants which are most likely to be observed in specimens
liquids). Materials that on account of their physical form or environmental collected from a healthy worker who has been exposed to chemicals to the same
conditions can form explosive mixtures with air and are readily dispersed in air. extent as a worker with inhalation exposure to the TLV.
Flammable or combustible dusts with representative diameter less than 420 ECOLOGICAL INFORMATION:
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids determine if a substance will concentrate in life forms that consume contaminated
containing greater than 0.5% by weight of a flammable or combustible solvent are plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or of Oil/Water Distribution is used to assess a substance's behavior in the
completely vaporize at atmospheric pressure and normal ambient temperature or environment.
that are readily dispersed in air and will burn readily. Flammable gases.
REGULATORY INFORMATION:
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
U.S.:
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that ignite when exposed to
Governmental Industrial Hygienists, a professional association that establishes
air, Solids containing greater than 0.5% by weight of a flammable or combustible
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
solvent are rated by the closed cup flash point of the solvent.
NIOSH: National Institute of Occupational Safety and Health, which is the
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
research arm of OSHA. DOT: U.S. Department of Transportation. TC: Transport
under fire conditions. Materials that have an instantaneous power density (product
Canada. SARA: Superfund Amendments and Reauthorization Act. TSCA: U.S.
of heat of reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL.
Toxic Substance Control Act. CERCLA: Comprehensive Environmental
Materials that do not exhibit an exotherm at temperatures less than or equal to
Response, Compensation, and Liability Act. Marine Pollutant status according to
500癈 (932癋) when tested by differential scanning calorimetry. 1 Materials that in
the DOT; CERCLA or Superfund; and various state regulations. This section also
themselves are normally stable, but that can become unstable at elevated
includes information on the precautionary warnings that appear on the material's
temperatures and pressures. Materials that have an instantaneous power density
package label.
(product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 0.01
CANADA:
W/mL and below 10 W/mL. WHMIS: Canadian Workplace Hazardous Materials Information System. TC:
Transport Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances
List.
MOMETASONE FUROATE OINTMENT 0.1% MSDS EFFECTIVE DATE: MAY 10, 2008
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