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 Gel USP, 0.05%
Synonyms: Not applicable.
CAS #: M ixture.
Chemical Family: Topical steroid gel.
Formula: Fluocinonide, Propylene Glycol, Carbomer 940, Edetate Disodium, Propyl Gallate, Sodium Hydroxide
and/or Hydrochloric Acid, and W ater.
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): 0-1-0 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, 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
Fluocinonide 356-12-7 0.05% no no no not established
Propylene Glycol 57-55-6 no no no not established
Carbomer 940 9003-01-4 no no no not established
Edetate Disodium 139-33-3 no no no not established
Propyl Gallate 121-79-9 no no no not established
Sodium Hydroxide 1310-73-2 no no no not established
Hydrochloric Acid 7647-01-0 no no no not established
Water 7732-18-5 no no no not established
M SDS# 04A Fluocinonide Gel USP, 0.05% (October 25, 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: Foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: Do not store or mix with oxidants or bases.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid oxidants, bases, flame, heat and light.
Hazardous Combustion or Carbon dioxide, Carbon monoxide
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.
M SDS# 04A Fluocinonide Gel USP, 0.05% (October 25, 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 oxidants, bases,
flame, heat and light. Store at controlled room temperature 15 o-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
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
oxidants, bases, flame, heat and light. Store at controlled room temperature
15 o-30 oC (59 o-86 o F).
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. Not for ophthalmic
use. (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: No applicable.
Shipping Instructions: Do not handle or store near oxidants, bases, flame, heat and light.
M SDS# 04A Fluocinonide Gel USP, 0.05% (October 25, 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: NDC: 0168-0135-15
0168-0135-60
SECTION 13: PHYSICAL DATA
Appearance and Odor: A translucent, smooth and homogenous, colorless to-white/off-white gel with a slight
odor of propylene glycol.
M olecular W eight: Not applicable.
pH: Not applicable.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
105 oC (221 oF)
Boiling Point:
Freezing/M elting Point: Does not melt.
Congealing Point: Not determined. not applicable.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Soluble.
Solubility in Alcohol: Soluble.
Solubility in Oil: Insoluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 1.05
% Volatile by Volume: Not determined.
Evaporation Rate (Ether=1): Hygroscopic.
Date of Preparation/Change: Revision Replaces
October 25, 2004 #1 January 26, 1995
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 Gel USP, 0.05% (October 25, 2004) Page 4 of 4
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