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: Clobetasol Propionate Topical Solution USP, 0.05%
Synonyms: None.
CAS #: M ixture.
Chemical Family: Topical Steroid.
Formula: Clobetasol Propionate, Isopropyl Alcohol, Carbomer 934P, Sodium Hydroxide NF and W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?2 RATINGS
Flammability: 2 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 1鈥?1鈥?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: Flush mouth with water. Give two glasses of water and induce vomiting, if directed by medical personnel.
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
Clobetasol Propionate 25122-46-7 0.05% no no no not established
Isopropyl Alcohol 67-63-0 no no no 200ppm 400ppm
Carbomer 934P 9003-01-4 no no no not established
2mg/m3 * 2mg/m3
Sodium Hydroxide 1310-73-2 no no no
Water 7732-18-5 no no no not established
* ceiling
M SDS# 05A Clobetasol Propionate Topical Solution USP, 0.05% (M arch 30, 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: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing when
firefighting
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid heat, flame, light, oxidants and bases.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. May cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis, manifestations
of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. May cause allergic reaction and skin
irritation in sensitive individuals.
b. Chronic Effects b. Systemic absorption may cause effects similar to overexposure. Possible irritation, teratogen,
system toxicity, hyperglycemia and glucosuria.
1. Inhalation: 1. May cause nausea, intoxication, depression on the CNS, headache, decreased blood rate,
coma, irritation to respiratory system.
2. Eyes: 2. May cause irritation or injury.
3. Skin: 3. May cause irritation.
4. Ingestion: 4. May cause nausea, intoxication, depression on CNS, headache, decreased blood rate, coma.
5. Medical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy in
Potentially Aggravated: sensitive individuals. Respiration and skin conditions.Hypersensitivity to any of the
ingredients.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Store at controlled room temperature
15o 鈥?30o C (59o 鈥?86o F). Do not refrigerate. Do not handle or store near heat, flame, light, oxidants
Handling/Storage:
and bases.
Hygienic Practices: Wash 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.
When Material is Released or Spilled: Avoid any ignition sources. Use non-sparking tools. Absorb on sand or vermiculite and place in
closed containers for disposal. Ventilate and wash area after material pickup is complete,
Report major leaks and spills to the appropriate local, state and/or federal governmental
agency.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at
approved incineration or chemical landfill waste disposal site.
M SDS# 05A Clobetasol Propionate Topical Solution USP, 0.05% (M arch 30, 2005) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORMATION
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
Special Precautions: Keep container closed when not in use. Keep container closed when not in use. Store
at controlled room temperature 15o鈥?30oC (59o鈥?86oF). Do not refrigerate. Do not
handle or store near heat, flame, light, oxidants and bases.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, flame and heat.
Container Should be Handled in an Area with: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For topical dermatologic use
only. Not for ophthalmic use.
Warning Placard: Flammable liquid.
IMO Hazard Class #: 9
UN/NA #: NA
Hazard Classification: ORM-D
DOT Name: Consumer Commodity
Shipping Instructions: Keep away from heat, flame, light, oxidants and bases.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: 49 CFR 172.101
EPA Regulations: SARA Title III, Section 311/312, Health (Immediate) and Flammable
Other: FDA: Not applicable.
NDC: 0168-0269-25
0168-0269-50
M SDS# 05A Clobetasol Propionate Topical Solution USP, 0.05% (M arch 30, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A slightly opalescent, colorless solution with an odor of isopropyl alcohol.
Molecular Weight: Not applicable.
pH: 4.5鈥?6.0
Refractive Index @ 20oC: Not determined.
Viscosity @ 25oC: Not determined.
Refluxes @ 50o C (122oF)
Boiling Point:
Freezing/Melting Point: Not determined.
Congealing Point: Not applicable.
Vapor Pressure (mm Hg @ 20oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Miscible.
Solubility in Alcohol: Miscible.
Solubility in Oil: Immiscible.
Solubility in Other: Not determined.
0.94 @ 20oC
Specific Gravity (H2 O=1):
% Volatile by Volume: ~39% (w/w) isopropyl alcohol
Evaporation Rate (Ether=1): 0.23
Date of Preparation/Change: Revision # 2 Replaces
March 30, 2005 October 25, 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. We 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 Material
Safety Data Sheet was prepared for ALTANA INC. by:
COMPLIANCE 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 Clobetasol Propionate Topical Solution USP, 0.05% (M arch 30, 2005) Page 4 of 4
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