MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
Emergency Telephone No.: (631) 454-7677
SECTION 1: IDENTITY
Product Name: Diflorasone Diacetate Ointment USP, 0.05%
Synonyms: None.
CAS #: None.
Chemical Family: Topical Steroid Ointment
Formula: Diflorasone Diacetate, Glyceryl Monostearate, Propylene Glycol, and White Petrolatum USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-2 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-1 Moderate 2
Special Hazards: Not indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. (Not under standard application.) Extreme 4
SECTION 3: EMERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: Wash 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
Diflorasone Diacetate 33564-31-7 no no no not established
Glyceryl Monostearate 31566-31-1 no no no not established
Propylene Glycol 57-55-6 no no no not established
White Petrolatum 8009-03-8 no no no not established
M SDS# 05A Diflorasone Diacetate Ointment USP, 0.05% (M arch 15, 2005) 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 Media: Foam, Dry chemical, Carbon dioxide, Smothering Agent
Special Fire Fighting Procedures: Use self-contained breathing apparatus when firefighting.
Unusual Fire and Explosion Hazards: May 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 Decomposition Carbon dioxide, Carbon monoxide, Toxic fumes of fluorine
Products:
Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. Possible burning, itching, irritation and dryness.
b. Chronic Effects: b. Possible hypersensitivity and a wide variety of systemic effects.
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. May cause irritation. Not for ophthalmic use.
3. Skin: 3. May cause irritation.
4. Ingestion: 4. May cause irritation.
5. Medical Conditions 5. Hypersensitivity to any of the ingredients.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store at controlled room temperature 15o-30oC
Precautions to be Taken in
(59o -86oF). Avoid heat, light, oxidants and bases. Care to avoid slippery conditions.
Handling/Storage:
Hygienic Practices: Wash thoroughly after handling.
When Material is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash area
with soap and water. Dispose of in accordance with federal, state and local regulations.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at
approved incineration or chemical landfill waste disposal site.
SECTION 9: SPECIAL PROTECTION INFORMATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
M SDS# 05A Diflorasone Diacetate Ointment USP, 0.05% (M arch 15, 2005) Page 2 of 4
SECTION 10: CONTAINERS and LABELING
Keep container closed when not in use. Store at controlled room temperature 15o-30oC
Special Precautions:
(59o-86oF).
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. For external use only. Not for
ophthalmic use. (See package insert.)
Warning Placard: Keep out of reach of children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from heat, light, oxidants and alkalies.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0243-15
0168-0243-30
0168-0243-60
M SDS# 05A Diflorasone Diacetate Ointment USP, 0.05% (M arch 15, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A translucent, white-to-off white ointment, smooth and homogeneous. No characteristic odor.
Molecular Weight: Not applicable.
pH: 4.0鈥?7.0
Refractive Index @ 20oC: Not determined.
Viscosity (CPS @ 25o C): 150,000鈥? 900,000
>190oC (374oF)
Boiling Point:
Melts @ 50o C (122oF)
Freezing/Melting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20O C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Immiscible.
Solubility in Alcohol: Very slightly miscible
Solubility in Oil: Miscible.
0.82鈥?0.90@ 60oC
Specific Gravity (H2 0=1):
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision 1 Replaces
March 16, 2005 December 28, 1999
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# 05A Diflorasone Diacetate Ointment USP, 0.05% (M arch 15, 2005) Page 4 of 4
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