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 Valerate Cream USP, 0.1%
Synonyms: Betatrex.
CAS #: Not applicable.
Chemical Family: Corticosteroid Cream.
Formula: Betamethasone Valerate, Purified Water, Mineral Oil, White Petrolatum, PEG 1000 Monocetyl Ether, Chlorocresol,
Cetostearyl Alcohol, and Sodium Phosphate Monobasic, Monohydrate. May contain Phosphoric Acid or Sodium
Hydroxide for pH adjustment.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-0 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
Betamethasone Valerate 2152-44-5 0.1 no no no not established
Water 7732-18-5 no no no not established
5mg/m3 * 5mg/m3*
Mineral Oil 8012-95-1 no no no
White Petrolatum 8009-03-8 no no no not established
PEG 1000 Monocetyl Ether 9004-95-9 no no no not established
Chlorocresol 59-50-7 no no no not established
Cetostearyl Alcohol 8005-44-5 no no no not established
Sodium Phosphate Monobasic, Monohydrate 10049-21-5 no no no not established
1mg/m3 1mg/m3
Phosphoric Acid 7664-38-2 no no no
2mg/m ** 2mg/m3
3
Sodium Hydroxide 1310-73-2 no no no
* as mist
** as STEL Ceiling
M SDS# 05A Betamethasone Valerate Cream USP, 0.1% (M arch 28, 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.
Special Fire Fighting Procedures: Use self-contained breathing apparatus when firefighting.
Unusual Fire and Explosion Hazards: May react with acids, bases and oxidizers.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidants, strong acids, bases and extreme heat.
Hazardous Combustion or Decomposition Carbon dioxide, Carbon monoxide.
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. May cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis, manifestations
of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. May cause allergic reaction and skin
irritation in sensitive individuals.
b. Chronic Effects: b. Systemic absorption may cause effects similar to overexposure.
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. No expected under normal conditions of use. Systemic absorption may cause effects similar to
4. Ingestion: overexposure.
5. Medical Conditions 4. May cause hyperglycemia and glycosuria.
Potentially Aggravated: 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy in
sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store at controlled room temperature 15o鈥?30oC
Precautions to be Taken in
(59o 鈥?86oF). Avoid strong oxidants, strong acids, bases and extreme heat.
Handling/Storage:
Hygienic Practices: Wash 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.
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.
M SDS# 05A Betamethasone Valerate Cream USP, 0.1% (M arch 28, 2005) Page 2 of 4
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.
SECTION 10: CONTAINERS and LABELING
Keep container closed when not in use. Store at controlled room temperature 15o鈥?30oC
Special Precautions:
(59o 鈥?86oF). Avoid strong oxidants, strong acids, bases and extreme 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 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.)
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 oxidizers, strong acids, bases and heat.
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: 0168-0040-15
0168-0040-46
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white cream with a slight odor.
Molecular Weight: Not applicable.
pH: 4鈥?6
Refractive Index @ 20oC: Not applicable.
Viscosity: Not determined.
100oC (212oF)
Boiling Point:
40鈥?50o C (100o鈥?122o F)
Freezing/Melting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20o C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Partially soluble.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Partially soluble.
Specific Gravity (H2 O=1): <1.0
% Volatile by Volume: 70 (water)
Evaporation Rate (Ether=1): 0.02
M SDS# 05A Betamethasone Valerate Cream USP, 0.1% (M arch 28, 2005) Page 3 of 4
Date of Preparation/Change: Revision # 2 Replaces
March 28, 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 Valerate Cream USP, 0.1% (M arch 28, 2005) Page 4 of 4
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