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 Cream USP, 0.05% (Emollient)
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical steroid.
Formula: Clobetasol Propionate, Propylene Glycol, Citric Acid, Sodium Citrate, Imidurea, Isopropyl M yristate,
Dimethicone 360, Cetomacrogol 1000, Cetostearyl Alcohol 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): 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 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 no no no none established
Propylene Glycol 57-55-6 no no no none established
Citric Acid 77-92-9 no no no none established
Sodium Citrate 68-04-2 no no no none established
Imidurea 39236-46 no no no none established
Isopropyl Myristate 110-27-0 no no no none established
Dimethicone 360 63148-62-9 no no no none established
Cetomacrogol 1000 9004-95-9 no no no none established
Cetostearyl Alcohol 8005-44-5 no no no none established
Water 7732-18-5 no no no none established
M SDS# 04A_Clobetasol Propionate Cream USP, 0.05% (Emollient) (October 25, 2004) 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, water spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
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 Decomposition Products: Carbon monoxide, 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. Possible hypersensitivity, irritation.
b. Chronic Effects: b. Possible irritation, HPA axis suppression, teratogen.
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. M ay cause irritation and corneal ulcers.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause irritation.
5. M edical Conditions 5. Hypersensitivity to any of the ingredients. HPA dysfunction.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use and away from heat, light, oxidants and bases.
Handling/Storage:
Hygienic Practices: Use proper personal hygiene to protect hands, eyes and skin.
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# 04A_Clobetasol Propionate Cream USP, 0.05% (Emollient) (October 25, 2004) 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 closed when not in use. Keep aw ay 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 an Area with: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For
dermatological 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: 21CFR 330.5
NDC: 0168-0301-15
0168-0301-30
0168-0301-60
M SDS# 04A_Clobetasol Propionate Cream USP, 0.05% (Emollient) (October 25, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A shiny, white cream with no discernible odor.
M olecular W eight: Not applicable.
pH: 4.5 -6.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 10,000 - 150,000 cps
Approximately 111 oC (231.8 oF)
Boiling Point:
M elts at approximately 31 oC (87.8 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: Disperses.
Solubility in Alcohol: Disperses.
Solubility in Oil: Insoluble.
Solubility in Other: Not determined.
0.96 @ 50 oC (122 oF)
Specific Gravity (H 2O=1):
% Volatile by Volume: Approximately 70% (water).
Evaporation Rate (Ether=1): 0.04
Date of Preparation/Change: Revision # 1 Replaces
October 25, 2004 November 23, 1998
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# 04A_Clobetasol Propionate Cream USP, 0.05% (Emollient) (October 25, 2004) Page 4 of 4
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