MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COM PANY DIVISION
PHARM ADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: M ometasone Furoate Cream USP, 0.1%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical Anti-inflammatory
Formula: Propylene Glycol M onostearate, Beeswax NF, Stearyl Alcohol and Ceteareth 20, W hite Petrolatum USP,
Aluminum Starch Octenyl Succinate, Hexylene Glycol NF, M ometasone Furoate USP, Purified W ater
USP, Phosphoric Acid NF, and Titanium Dioxide USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-1 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: W ash thoroughly with soap and water.
Ingestion: Give two glasses of water and induce vomiting. Never give anything by mouth to an unconscious person.
Inhalation: Remove to fresh air. If breathing is difficult, give oxygen. If breathing has stopped, give artificial respiration.
CALL A PHYSICIAN
CONTACT A POISON CONTROL CENTER
SECTION 4: INGREDIENTS
C A R C IN O G E N H A ZA R D D A T A
A C G IH O SH A
NAM E C A S# % IA R C NTP O SH A TLV PEL
10 m g/m 3 **
Propylene Glycol Monostearate 1323-39-3 no no no not applicable
Beeswax 8012-89-3 no no no not applicable
Stearyl Alcohol 112-92-5 no no no not applicable
Ceteareth 20 68439-49-6 no no no not applicable
White Petrolatum 8009-03-8 no no no not applicable
Aluminum Starch Octenyl Succinate 9087-61-0 no no no not applicable
121mg/m 3 *
Hexylene Glycol 107-41-5 no no no not applicable
Mometasone Furoate 83919-23-7 no no no not applicable
Water 7732-18-5 no no no not applicable
1 m g/m 3 1 m g/m 3
Phosphoric Acid 7664-38-2 no no no
Titanium Dioxide 13463-67-7 no no no 1 m g/m 3 1 m g/m 3
*ceiling **stearates
M SDS# 05A _M ometasone Furoate Cream USP, 0.1% (June 3, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature oF: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Dry chemical, Carbon Dioxide, Foam, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid heat, light, oxidants and bases.
Hazardous Combustion or Decomposition Products: Carbon M onoxide, Carbon Dioxide.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause reversible suppression of the Hypothalamic-Pituitary-Adrenal Axis,
symptoms of Cushing鈥檚 Syndrome, hyperglycemia and glycosuria.
b. Chronic Effects: b. Possible hypersensitization.
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause hyperglycemia and glycosuria.
5. M edical Conditions 5. Hypersensitivity to any of the ingredients, HPA dysfunction.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store between 2 o and 25 oC (36 o and 77 oF). Do
Precautions to be Taken in
Handling/Storage: not handle or store near heat, light, oxidants and bases.
Hygienic Practices: W ash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
Use general ventilation to protect your lungs. Do not wear contaminated clothing
until thoroughly laundered.
W hen M aterial is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove.
W ash area with soap and water. Dispose of in accordance with federal, state and local
regulations.
W aste Disposal M ethods: Assure conformity with applicable disposal regulations. Dispose of absorbed material
at approved incineration or chemical landfill waste disposal site.
M SDS# 05A _M ometasone Furoate Cream USP, 0.1% (June 3, 2005) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
SECTION 10: CONTAINERS and LABELING
Keep container closed when not in use. Store between 2 o and 25 oC (36 o and 77 oF) and away
Special Precautions:
from heat, light, oxidants and bases.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and heat.
Container Should be Handled in Adequate, general ventilation.
an Area with:
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For dermatologic use only. Not
for ophthalmic use.
W arning Placard: Keep Out of Reach of Children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from heat, light, oxidants and bases.
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORM ATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA:
NDC: 0168-0270-15
0168-0270-46
M SDS# 05A _M ometasone Furoate Cream USP, 0.1% (June 3, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white, smooth and homogeneous cream, with a slight characteristic odor.
M olecular W eight: Not applicable.
pH: 4.0 -6.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 30,000 - 100,000 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not applicable.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Disperses.
Solubility in Alcohol: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not applicable.
0.85 - .95 @ 50 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: M inimal.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
June 3, 2005 October 12, 2004
The information presented herein relates to the specific material described and may not be valid for this material used in
combination with any other materials or in any process. This information is, to the best of our knowledge, accurate and reliable on
the date compiled. W e make no representation, warranty or guarantee as to its accuracy, reliability or completeness.
It is the reader's responsibility to ascertain whether the information supplied is suitable and complete for that person's specific
uses. This M aterial Safety Data Sheet was prepared for ALTANA INC. by:
COM PLIANCE INNOVATIONS, INC.
706 Route 15 South, Suite 207
Lake Hopatcong, New Jersey 07849
973-663-1120 鈥? fax 973-663-2378
helpdesk@chemply.com
M SDS# 05A _M ometasone Furoate Cream USP, 0.1% (June 3, 2005) Page 4 of 4
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