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MSDS Material Safety Data Sheet
CAS

5593-20-4
7732-18-5
8009-03-8

File Name: fougera_com---1059.msds.asp
                                   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 Cream USP, 0.05%
Synonyms: Alphatrex.
CAS #: None.
Chemical Family: Corticosteroid.
Formula: Betamethasone Dipropionate USP, Purified W ater USP, W hite Petrolatum USP, M ineral Oil USP,
Cetomacrogol or PEG 20 Stearate (PEG 1000 M onocetyl Ether), P-Chloro-M -Cresol (Chlorocresol NF),
Cetostearyl Alcohol NF, and M onobasic Sodium Phosphate USP. M ay contain either Phosphoric Acid or
Sodium Hydroxide for pH adjustment.



SECTION 2: SAFETY and HAZARD RATINGS

Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0鈥?1鈥?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




M SDS# 05A Betamethasone Dipropionate Cream USP, 0.05% (M arch 29, 2005) Page 1 of 4
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 0.05 no no no not established
Water 7732-18-5 no no no not established
White Petrolatum 8009-03-8 no no no not established
5mg/m3 5mg/m3
Mineral Oil 8012-95-1 no no no
Cetomacrogol or PEG 20 Stearate (PEG 1000 Monocetyl Ether) 68439-49-6 no no no not established
P-Chloro-M-Cresol (Chlorocresol) 59-50-7 no no no not established
Cetostearyl Alcohol 8005-44-5 no no no not established
Monobasic Sodium Phosphate, Monohydrate 7558-80-7 no no no not established
1mg/m3 1mg/m3
Phosphoric Acid 7664-38-2 no no no
2mg/m3* 2mg/m3
Sodium Hydroxide 1310-73-2 no no no
* ST E L C eiling


SECTION 5: FIRE and EXPLOSION HAZARD DATA

Does not flash before boiling at ~100 oC (212 oF).
Flash Point:
Auto-ignition Temperature oF: 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 when firefighting.
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 strong oxidizers, acids, bases and extreme heat.

Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.

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 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 glycosuria.
5. M edical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and
Potentially Aggravated: allergy in sensitive individuals.




M SDS# 05A Betamethasone Dipropionate Cream USP, 0.05% (M arch 29, 2005) Page 2 of 4
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES

Precautions to be Taken in Keep container closed when not in use. Store at controlled room temperature
15 o鈥?30 oC (59 o鈥?86 oF). Avoid strong oxidizers, acids, bases and extreme heat.
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. Store at controlled room
temperature 15 o鈥?30 oC (59 o鈥?86 oF).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and extreme 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 dermatologic
use only. 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: Not applicable.
Shipping Instructions: Keep aw ay from strong oxidizers, acids, bases and extreme heat.



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: 0168-0055-15
0168-0055-46




M SDS# 05A Betamethasone Dipropionate Cream USP, 0.05% (M arch 29, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA

Appearance and Odor: A white cream with practically no odor.
M olecular W eight: Not applicable.
pH: 4鈥?6 (10% in water)
Refractive Index @ 20 oC: Not determined.
Viscosity: Not determined.
100 oC (212 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: Partially soluble.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Partially soluble.
Solubility in Other: Not determined.
0.96 @ 20 oC
Specific Gravity (H 20=1):
% Volatile by Volume: 70
Evaporation Rate (Ether=1): 0.02


Date of Preparation/Change: Revision # 2 Replaces
M arch 29, 2005 November 29, 2001

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 Betamethasone Dipropionate Cream USP, 0.05% (M arch 29, 2005) Page 4 of 4

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