MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. 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: Fluticasone Propionate Ointment, 0.005%
Synonyms: None.
CAS #: M ixture.
Chemical Family: Topical Corticosteroid Ointment.
Formula: Fluticasone Propionate, Propylene Glycol, Sorbitan Sesquioleate, M icrocrystalline W ax, Liquid
Paraffin.
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?1鈥?0
Severe 3
Special Hazards: Not indicated.
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
Fluticasone Propionate 80474-14-2 0.005 no no no not established
Propylene Glycol 57-55-6 no no no not established
Sorbitan Sesquioleate 8007-43-0 no no no not established
Microcrystalline Wax 63231-60-7 no no no not established
Liquid Paraffin 8012-95-1 no no no not established
M SDS# 06A Fluticasone Propionate Ointment, 0.005% (M arch 14, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature NF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning.
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 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. M ay 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 Keep container closed when not in use. Store between 2N鈥?30NC (36N鈥?86NF). Avoid
Handling/Storage: heat, light, oxidants and bases.
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 Fluticasone Propionate Ointment, 0.005% (M arch 14, 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.
SECTION 10: CONTAINERS and LABELING
Keep container closed when not in use. Store between 2N鈥?30NC (36N鈥?86 NF).
Special Precautions:
Avoid heat, light, oxidants and bases.
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: 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.
W arning Placard: Not recommended for use on children under 12 years of age. 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: Avoid heat, light, oxidants and bases.
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: 0168-0333-15
0168-0333-30
0168-0333-60
M SDS# 06A Fluticasone Propionate Ointment, 0.005% (M arch 14, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: An odorless white to off-white, smooth and homogeneous ointment.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20NC: Not determined.
Viscosity CPS @ 25NC: 25,000-200,000
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Insoluble.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Specific Gravity (H 2O=1): Approximately 0.85 @ 60NC
% Volatile by Volume: Negligible.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
March 14, 2006 March 7, 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 Fluticasone Propionate Ointment, 0.005% (M arch 14, 2006) Page 4 of 4
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