MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. Fougera & Co.
PharmaDerm
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
Emergency Telephone No.: 800-424-9300
631-454-7677
SECTION 1: IDENTITY
Product Name: Fluocinolone Acetonide Topical Solution USP, 0.01%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Fluorinated topical corticosteroid.
Formula: Fluocinolone acetonide, Propylene glycol, and Citric acid.
SECTION 2: SAFETY and HAZARD RATINGS
RATINGS
Health (Acute-Chronic): 1鈥?1
Minimal 0
Flammability: 1
Slight 1
Reactivity: 0
Moderate 2
Environment (Air-W ater-Soil): 0鈥?2鈥?1
Severe 3
Special Hazards: None.
Extreme 4
Protective Equipment: General ventilation, eye and hand wash.
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
Fluocinolone acetonide 67-73-2 0.01 no no no not established
Propylene glycol 57-55-6 no no no not established
Citric acid 77-92-9 no no no not established
M SDS# 06A Fluocinolone Acetonide Topical Solution USP, 0.01% (December 15, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature 潞F: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay react with acids, bases and oxidizers.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid acids, bases, oxidizers and sources of heat.
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. None expected under normal condition of use.
2. Eyes: 2. Topical forms will cause moderate irritation. Not for ophthalmic use.
3. Skin: 3. No effects expected under normal conditions of use.
4. Ingestion: 4. M ay induce low toxicity.
5. M edical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy
Potentially Aggravated: in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Store at controlled room temperature 15潞鈥?30潞C (59潞鈥?86潞F). Protect from freezing. Do
Handling/Storage: not handle or store near strong acids, bases, oxidizers and sources of heat.
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.
M SDS# 06A Fluocinolone Acetonide Topical Solution USP, 0.01% (December 15, 2006) 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.
SE C T IO N 10: C O N T A IN E R S and L A B EL IN G
Special Precautions: Keep container closed when not in use. Store at controlled room
temperature 15潞鈥?30潞C (59潞鈥?86潞F). Protect from freezing. Avoid strong acids,
bases, oxidizers and sources of heat.
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 W ith: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For dermatologic
use only. Not for ophthalmic use. See PRECAUTIONS-Pediatric Use
(product 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 strong acids, bases, oxidizers and sources of heat. Protect
from freezing.
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: 0168-0059-60
M SDS# 06A Fluocinolone Acetonide Topical Solution USP, 0.01% (December 15, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A colorless solution that is essentially odorless.
M olecular W eight: Not applicable.
pH: 4
Refractive Index @ 20潞C: Not determined.
Viscosity: Not determined.
Boiling Point: 170潞鈥?188潞C (338潞鈥?370潞F)
Freezing/M elting Point: 鈥?60潞C (鈥?76潞F)
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20潞C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M iscible.
Solubility in Alcohol: M iscible.
Solubility in Oil: Insoluble.
Solubility in Other: Not indicated.
Specific Gravity (H 2O=1): 1.034 @ 25潞C
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 3 Replaces
December 15, 2006 November 17, 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. 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# 06A Fluocinolone Acetonide Topical Solution USP, 0.01% (December 15, 2006) Page 4 of 4
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