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: Fluocinonide Emollient Cream, 0.05%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical Corticosteroid.
Formula: Stearyl Alcohol NF, Cetyl Alcohol NF, Sorbitan M onostearate NF, M ineral Oil, USP, Propylene Glycol
USP, Purified W ater USP, Citric Acid USP (Anhydrous) Polysorbate 60NF, Fluocinonide USP.
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): 0-1-1 M oderate 2
Special Hazards: Not indicated. 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. 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
M SDS# 04A Fluocinonide Emollient Cream, 0.05% (July 1, 2004) Page 1 of 4
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
Stearyl Alcohol 112-92-5 no no no not established
Cetyl Alcohol 36653-82-4 no no no not established
Sorbitan Monostearate 1338-41-6 no no no not established
Mineral Oil 8042-47-5 no no no not established
Propylene Glycol 57-55-6 no no no not established
Purified Water 7732-18-5 no no no not established
Citric Acid (Anhydrous) 77-92-9 no no no not established
Polysorbate 60 9005-67-8 no no no not established
Fluocinonide 356-12-7 no no no not established
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: Not determined.
Special Fire Fighting Procedures: Alcohol foam, dry chemical, carbon dioxide, water.
Unusual Fire and Explosion Hazards: Use self-contained breathing apparatus and protective clothing. M ay react with
bases and oxidizers.
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 Dioxide, Carbon M onoxide
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: M ay cause skin irritation and allergic reactions in sensitive individuals.
b. Chronic Effects: M ay cause skin irritation and allergic reactions in sensitive individuals.
1. Inhalation: None expected under normal condition of use.
2. Eyes: Topical forms will cause moderate irritation. Not for ophthalmic use.
3. Skin: No effects expected under normal condition of use.
4. Ingestion: M ay induce low toxicity.
5. M edical Conditions None.
Potentially Aggravated:
M SDS# 04A Fluocinonide Emollient Cream, 0.05% (July 1, 2004) Page 2 of 4
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: 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.
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. Do not handle or store near heat, flame or oxidizers.
Store at 20 o-25 oC (68 o-77 oF). Avoid excessive heat (above 40 oC [104 oF]).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and heat.
Container Should be Handled Adequate general ventilation.
in an Area with:
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For topical 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: No applicable.
Shipping Instructions: Do not handle or store near heat, flame or oxidizers.
M SDS# 04A Fluocinonide Emollient Cream, 0.05% (July 1, 2004) Page 3 of 4
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:
NDC: 0168-0246-15
0168-0246-30
0168-0246-60
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white cream with negligible odor.
M olecular W eight: Not applicable.
pH: 3.5 - 6.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 50,000 - 150,000 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: Disperses.
Solubility in Alcohol: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
Specific Gravity (@ 50 oC): 0.955 - 1.000
% Volatile by Volume: Approximately 60% as water
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision Replaces
July 1, 2004 #0 Not Applicable
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 w hether 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 Fluocinonide Emollient Cream, 0.05% (July 1, 2004) Page 4 of 4
|