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
Betamethasone Dipropionate Lotion USP, 0.05%
Product Name:
Alphatrex
Synonyms:
Not applicable.
CAS #:
Corticosteroid Lotion
Chemical Family:
Betamethasone Dipropionate USP, Isopropyl Alcohol USP, Carbomer 934P NF and Purified W ater USP.
Formula:
M ay contain Sodium Hydroxide or Phosphoric Acid for pH adjustment.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 3 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-0 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 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. 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 0.05 no no no not established
Isopropyl Alcohol 67-63-0 50.0 no no no 400ppm 400ppm
Carbomer 934P 9003-01-4 no no no not established
Water 7732-18-5 no no no not established
2mg/m3 * 2mg/m3
Sodium Hydroxide 1310-73-2 no no no
1mg/m3 1mg/m3
Phosphoric Acid 7664-38-2 no no no
* STE L C eiling
M SDS# 05A Betamethasone Dipropionate Lotion USP, 0.05% (M arch 31, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
20 oC (58 oF) (open cup)
Flash Point:
Auto-ignition Temperature oF: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning. 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, strong acids, bases and extreme heat.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
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. M ay cause irritation.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. Not 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 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. Do not handle or store near oxidizers, acids,
bases and extreme heat. Store at controlled room temperature 15 o鈥?30 oC (59 o鈥?86 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
until thoroughly laundered.
W hen M aterial is Released or Spilled: Avoid any ignition sources. Use non-sparking tools. Absorb on sand or vermiculite
and place in closed containers for disposal. Ventilate and wash area after material
pickup is complete, Report major leaks and spills to the appropriate local, state
and/or federal governmental agency.
W aste Disposal M ethods: Assure conformity with applicable disposal regulations. Dispose of absorbed material
at approved incineration or chemical landfill waste disposal site.
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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. Do not handle or store near oxidizers,
acids, bases and extreme heat. 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, flame 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. Not for ophthalmic
use. (See package insert.)
W arning Placard: Flammable liquid. Keep out of the reach of children.
IM O Hazard Class #: 9
UN/NA #: Not applicable.
Hazard Classification: ORM -D
DOT Name: Consumer Commodity
Shipping Instructions: Keep aw ay from 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: 49 CFR 172.101
EPA Regulations: SARA Title III, Section 311/312, Health (Immediate) and Flammable
Other: NDC: 0168-0057-60
M SDS# 05A Betamethasone Dipropionate Lotion USP, 0.05% (M arch 31, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white lotion that is practically odorless.
M olecular W eight: Not applicable.
pH: 4鈥?6 (10% in water)
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
80 o鈥?85 oC (176 o鈥?185 oF)
Boiling Point:
40 o鈥?50 oC (100 o鈥?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: Disperses.
Solubility in Alcohol: Disperses.
Solubility in Oil: M ostly insoluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): <1.0
% Volatile by Volume: 50% Isopropyl alcohol
Evaporation Rate (Ether=1): 0.02
Date of Preparation/Change: Revision # 2 Replaces
M arch 31, 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
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