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 Gel, 0.05%
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Topical Steroid.
Formula: Clobetasol Propionate, Propylene Glycol, Carbomer 934P, Sodium Hydroxide, and Purified W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-2 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 1-1-1 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: 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
Propylene Glycol 57-55-6 no no no not established
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 Gel, 0.05% [M arch 29, 2005] Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature 0F: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
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, light, oxidants and bases.
Hazardous Combustion or Carbon monoxide, Carbon dioxide.
Decomposition Products:
Hazardous Polymerization: [ ] M ay Occur [ X ] W ill Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Inhalation, Ingestion.
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. Systemic absorption may cause effects similar to overexposure.
b. Chronic Effects:
1. Nausea, intoxication, depression on CNS, headache, decreased blood rate, coma,
1. Inhalation:
irritation to respiratory system
2. M ay cause injury. For topical dermatologic use only. Not for ophthalmic, oral or
2. Eyes:
intravaginal use.
3. M ay cause irritation.
3. Skin:
4. Nausea, intoxication, depression on CNS, headache, decreased blood rate, coma.
4. Ingestion:
5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy in
5. M edical Conditions
sensitive individuals.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container tightly closed when not in use. Do not handle or store near flame,
heat, light, oxidants and bases. Store between 15 o鈥?30 oC (59 o鈥?86 oF).
Handling/Storage:
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 Clobetasol Propionate Gel, 0.05% [M arch 29, 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
Special Precautions: Keep container tightly closed when not in use. Keep away from oxidizers and
bases and sources of heat and flame. Store between 15 o鈥?30 oC (59 o鈥?86 oF).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, sources of heat and flame.
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, oral or intravaginal use.
W arning Placard: Keep out of reach of children. (See package insert.)
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, oxidizers, 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: NDC: 0168-0293-15
0168-0293-30
0168-0293-60
M SDS# 05A Clobetasol Propionate Gel, 0.05% [M arch 29, 2005] Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A translucent, smooth and homogenous gel with a slight characteristic odor.
M olecular W eight: Not applicable.
pH: 4.0鈥?7.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 25,000鈥?60,000 cps
~55 oC (131 oF)
Boiling Point:
~115 oC (349 oF)
Freezing/M elting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M iscible.
Solubility in Alcohol: M iscible.
Solubility in Oil: Immiscible.
Solubility in Other: Not determined.
0.97鈥?1.10 @ 25 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: ~33% (w/w) water
Evaporation Rate (Ether=1): 0.004
Date of Preparation/Change: Revision # 1 Replaces
M arch 29, 2005 December 28, 1999
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 Clobetasol Propionate Gel, 0.05% [M arch 29, 2005] Page 4 of 4
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