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 Ointment USP, 0.05%
Synonyms: Not applicable.
CAS #: M ixture.
Chemical Family: Pharmaceutical Topical Ointment.
Formula: Glyceryl M onostearate, W hite W ax, W hite Petrolatum, Propylene Glycol, Propylene Carbonate and
Fluocinonide.
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): 0-0-1 M oderate 2
Special Hazards: None indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. 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 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
10mg/m3*
Glyceryl Monostearate 31566-31-1 no no no not established
White Wax 8012-89-3 no no no not established
White Petrolatum 8009-03-8 no no no not established
Propylene Glycol 57-55-6 no no no not established
Propylene Carbonate 108-32-7 no no no not established
Fluocinonide 356-12-7 0.05 no no no not established
*as stearate
M SDS# 04A Fluocinonide Ointment USP, 0.05% (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, W ater Spray, Fog.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: None.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Avoid heat, flame, oxidants, bases and acids.
Chemicals to Avoid:
Hazardous Combustion or Oxides of Carbon (CO, CO 2) and Hydrogen fluoride.
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 reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis,
manifestations of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. M ay cause
allergic reaction and skin irritation in sensitive individuals.
b. Chronic Effects: b. Systemic absorption may cause effects similar to overexposure.
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. None expected under normal conditions of use. Systemic absorption may cause
effects similar to overexposure.
4. Ingestion: 4. M ay cause hyperglycemia and glucosuria.
5. M edical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and
Potentially Aggravated: allergy in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid heat, flame, oxidants, bases and acids.
Store at controlled room temperature 15 o-30 oC (59 o-86 oF). Avoid temperatures above
Handling/Storage:
30 oC (86 oF).
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 Fluocinonide Ointment USP, 0.05% (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. Avoid heat, flame, oxidants, bases
and acids.
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: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. (See package
insert.)
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, flame, oxidants, bases and acids.
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: 0168-0140-15
0168-0140-30
0168-0140-60
M SDS# 04A Fluocinonide Ointment USP, 0.05% (October 25, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white ointment with a slightly waxy odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
199 oC (390.2 oF)
Boiling Point:
52 oC (125.6 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: Insoluble.
Solubility in Alcohol: Insoluble.
Solubility in Oil: Soluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 0.87
% Volatile by Volume: 0.0
Evaporation Rate (Ether=1): 0.0
Date of Preparation/Change: Revision # 1 Replaces
October 25, 2004 November 26, 1996
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 Fluocinonide Ointment USP, 0.05% (October 25, 2004) Page 4 of 4
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