MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
(800) 424-9300 , (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5%
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Topical corticosteroid pharmaceutical cream.
Formula: Triamcinolone Acetonide USP (Micronized), Emulsifying Wax NF, Cetyl Alcohol 70% (non NF),
Isopropyl Palmitate NF, Purified Water USP, Sorbitol Solution USP, Glycerin USP, Lactic Acid 1%,
Benzyl Alcohol NF, Lactic Acid USP 88%.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-2-1 Moderate 2
Special Hazards: Not indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EMERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: Wash 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
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SECTION 4: INGREDIENTS
CARCINOGEN HAZARD DATA
ACGIH OSHA
NAME CAS# % IARC NTP OSHA TLV PEL
not established
Triamcinolone Acetonide no no
76-25-5 no
N/A no no no not established
Wax
no no not established
Cetyl Alcohol 124-29-8 no
not established
Isopropyl Palmitate 142-91-6 no no no
no no not established
Water 7732-18-5 no
not established
Sorbitol 50-70-4 no no no
no no not established
Glycerin 56-81-5 no
no no not established
Lactic Acid 50-21-5 no
no not established
Benzyl Alcohol 100-51-6 no no
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not applicable.
Auto-ignition Temperature OF: Not applicable.
Flammable Limits in Air by Volume LEL: Not applicable.
UEL: Not applicable.
Extinguishing Media: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: May react with acids, bases and extreme heat.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidizers, strong acids, bases and sources of heat.
Hazardous Combustion or Decomposition Products: May emit toxic fumes.
Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal.
Signs and Symptoms of Exposure
a. Overexposure Effects: May cause reversible suppression of Hypothalamic-Pituitary-Adrenal dysfunction, skin
irritation and allergic reactions in sensitive individuals.
b. Chronic Effects: Systemic absorption may cause effects similar to overexposure.
1. Inhalation: Not likely due to the physical state of the product.
2. Eyes: Will cause irritation. Not for ophthalmic use.
3. Skin: System absorption may cause effects similar to overexposure.
4. Ingestion: May cause hyperglycemia and glycosuria.
5. Medical Conditions Hypothalamic-Pituitary-Adrenal axis. May cause allergic reaction and skin irritation.
Potentially Aggravated:
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SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not handle or store near heat, flame or
Handling/Storage: oxidizers.
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 Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash
Spilled: area with soap and water. Dispose of in accordance with federal, state and local
regulations.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at
approved incineration or chemical landfill waste disposal site.
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. Avoid heat and flame.
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 external use
only. Use as directed. Not for ophthalmic use.
Warning Placard: Keep Out of Reach of Children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from oxidizers sources of heat.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
MSDS# 03A Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% (November 17, 2003) Page 3 of 4
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA If respirator used, 29 CFR 1910.134
Regulations: Not applicable.
DOT Regulations: Not applicable.
EPA Regulations: FDA: 21 CFR 330.5
Other: NDC: 0168-0002-15 0168-0004-15 0168-0003-15
0168-0004-80 0168-0003-80
0168-0004-16 0168-0003-16
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white cream that is essentially odorless.
Molecular Weight: Not applicable.
pH: 4.0 - 5.5
Refractive Index @ 20OC: Not applicable.
Viscosity @ 25OC: Not determined.
212OF (100OC)
Boiling Point:
Freezing/Melting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20OC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Disperses.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Partially soluble.
Solubility in Other: Not applicable.
< 1.0 @ 20OC
Specific Gravity (H2O=1):
% Volatile by Volume: Not determined.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 2 Replaces
November 17, 2003 March 31, 2003
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
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