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: Halobetasol Propionate Ointment, 0.05%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical Corticosteroid.
Formula: W hite Petrolatum USP, W hite Wax NF, Dehymuls E, Propylene Glycol USP, and Halobetasol Propionate.
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): 1-2-1 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: Gloves and goggles for large quantities. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush immediately with plenty of water for at least 15 minutes.
Skin: W ash immediately and thoroughly with soap and water. If redness, itching or burning sensation develops, get
medical attention.
Ingestion: Give 2-4 cups of milk or water to dilute. Never give anything by mouth to an unconcious person.
Inhalation: Not applicable with normal use. In cases of overexposure, remove to fresh air. If breathing is difficult, give
oxygen. If breathing has stopped, give artificial respiration. Contact a physician.
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
White Petrolatum 8009-03-8 no no no not established
White Wax 8006-40-4 no no no not established
Dehymuls E not applicable n/a n/a n/a not applicable
Propylene Glycol 57-55-6 no no no not established
Halobetasol Propionate 66852-54-8 no no no not established
M SDS# 04A Halobetasol Propionate Ointment, 0.05% (October 8, 2004) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined
Auto-ignition Temperature oF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: W ater, Carbon Dioxide, Dry Chemical, Foam.
Special Fire Fighting Procedures: W ear self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: None.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Avoid heat, light, oxidants and bases.
Chemicals to Avoid:
Hazardous Combustion or Carbon dioxide and Carbon monoxide may form when heated to decomposition.
Decomposition Products:
Hazardous Polymerization: [ ] M ay Occur [ X ] W ill 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 irritation of skin and eyes.
b. Chronic Effects: b. M ay cause mutagen and reproductive effects.
1. Inhalation: 1. None expected under normal conditions of use. Excessive exposure may result in
overexposure effects.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause suppression of HPA axis, gastrointestinal upset and temporary CNS
5. M edical Conditions depression.
Potentially Aggravated: 5. Kidney disorders, hypersensitivity to any of the components.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Product should be stored in cool, dry place, away from sources of heat. Store between 15 o
Precautions to be Taken in
and 30 oC (59 o-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 unless
thoroughly laundered.
W hen M aterial is Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove to
Released or Spilled: plastic-lined fiber containers immediately. 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 Halobetasol Propionate Ointment, 0.05% (October 8, 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
Keep container closed when not in use. Store between 15 o and 30 oC (59-
Special Precautions:
86 oC) and away from sources of heat, light, oxidants and bases.
Recommended Container: As supplied. (Not sold in bulk quantity.)
Protect the Container by: Avoiding physical damage and heat.
Container Should be Handled in an Area with: Temperature control.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For
dermatological use only. Not for opthalmic 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 sources of heat, light, oxidants and bases.
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not determined.
Biodegradability: Not determined.
Partition Coefficient: Not determined.
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: 0168-0356-45
M SDS# 04A Halobetasol Propionate Ointment, 0.05% (October 8, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white, smooth and homogeneous ointment.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 100,000 - 1,000,000 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Insoluble.
Solubility in Alcohol: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
0.800 - 0.950 @ 60 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: Negligible.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 0 Replaces
October 8, 2004 0
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 Halobetasol Propionate Ointment, 0.05% (October 8, 2004) Page 4 of 4
|