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: Betamethasone Dipropionate Ointment, 0.05% , Augmented
Synonyms: Not applicable.
CAS #: M ixture.
Chemical Family: Topical steroid.
Formula: Betamethasone Dipropionate, Propylene Glycol, W hite Petrolatum, W hite W ax NF, and Propylene Glycol
Stearate.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-2 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-1 M oderate 2
Special Hazards: None. 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
Betamethasone Dipropionate 5593-20-4 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
White Wax NF 8012-89-3 no no no not established
Propylene Glycol Stearate 1323-39-3 no no no not established
M SDS# 04A Betamethasone Dipropionate Ointment, 0.05% , Augmented (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: 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 Avoid heat, light, oxidants and bases.
Chemicals to Avoid:
Hazardous Combustion or W hen heated to decomposition, will produce carbon oxides (CO, CO 2) and Halogenated
Decomposition Products: compounds.
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. Possible eye, skin and/or respiratory tract irritation; suppression of adrenal gland
secretion; water retention; electrolyte imbalance; hyperglycemia; Cushing鈥檚
Syndrome. M ay cause embryotoxicity and developmental effects.
b. Chronic Effects: b. Possible hypersensitization, irritation.
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause irritation.
5. M edical Conditions 5. Hypersensitivity to any of the ingredients; systemic fungal infection.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid heat, light, oxidants and bases. Store
between 2 o and 25 oC (36 o-77 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 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 Betamethasone Dipropionate Ointment, 0.05% , Augmented (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, light, oxidants and
bases.
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, 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: 0168-0268-15
0168-0268-50
M SDS# 04A Betamethasone Dipropionate Ointment, 0.05% , Augmented (October 25, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A translucent, white to off-white ointment, smooth and homogeneous with no discernible
odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 70,000 - 275,000 cps
>190 oC (>374 oF)
Boiling Point:
50 oC (122 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: Immiscible.
Solubility in Alcohol: Very slightly miscible.
Solubility in Oil: M iscible.
Solubility in Other: Not determined.
0.80 - 0.90 @ 60 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 1.a Replaces
October 25, 2004 December 28, 1998
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 Betamethasone Dipropionate Ointment, 0.05% , Augmented (October 25, 2004) Page 4 of 4
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