MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC. - BYK PHARMACEUTICAL GROUP
Divisions: E. FOUGERA & COMPANY DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Clotrimazole and Betamethasone Dipropionate Lotion, USP.
Synonyms: None.
CAS #: None.
Chemical Family: Topical antifungal, corticosteroid combination.
Formula: Mineral Oil USP, Cetostearyl Alcohol NF, Ceteareth-30, White Petrolatum USP, Purified Water USP, Monobasic
Sodium Phosphate USP Monohydrate, Benzyl Alcohol NF, Propylene Glycol USP, Clotrimazole USP, Betamethasone
Dipropionate USP Crystal, Phosphoric Acid NF, Purified Water USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-1 Moderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. 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 plenty of water to drink and induce vomiting if directed by medical personnel. Never give anything by
mouth to an unconscious person.
Inhalation: Remove to fresh air. Give artificial respiration if breathing has stopped.
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
Mineral Oil 8042-47-5 no no no not established
Cetostearyl Alcohol 8005-44-5 no no no not established
Ceteareth-30 68349-49-6 no no no not established
White Petrolatum 8009-03-8 no no no not established
Monobasic Sodium Phosphate, Monohydrate 10049-27-5 no no no not established
Benzyl Alcohol 100-51-6 no no no not established
Propylene Glycol 57-55-6 no no no not established
Clotrimazole 23593-75-1 no no no not established
Betamethasone Dipropionate, Crystal 5593-20-4 no no no not established
Phosphoric Acid 7664-38-2 no no no not established
Purified Water 7732-18-5 no no no not established
M SDS# 04A Clotrimazole and Betamethasone Dipropionate Lotion, USP (August 9, 2004) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not applicable.
Auto-ignition Temperature oF: Not applicable.
Flammable Limits in Air by Volume Not applicable.
LEL: Not applicable.
UEL: Foam, Dry chemical, Carbon dioxide.
Extinguishing M edia: Use self-contained breathing apparatus.
Special Fire Fighting Procedures: M ay emit toxic fumes when burning, and may react with bases and oxidizers.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid heat, light, oxidants, and bases.
Hazardous Combustion or Carbon dioxide, Carbon monoxide.
Decomposition Products:
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 allergic reaction and skin irritation.
b. Chronic Effects
1. Inhalation: b1. Not likely due to the physical state of the product.
2. Eyes: b2. M ay cause irritation. Not for ophthalmic use.
3. Skin: b3. M ay cause irritation.
4. Ingestion: b4. Not expected under normal conditions of usage.
5. M edical Conditions b5. Skin irritation and allergy in sensitive individuals.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store in an upright position between 15 oC and
Precautions to be Taken in
30 oC (59 oF and 86 oF) and avoid heat, light, oxidants and bases.
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.
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SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: Adequate 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. Store in an upright position between 15 oC and 30 oC
Special Precautions:
(59 oF and 86 oF) and avoid heat, light, oxidants and bases.
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: General ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For topical use only.
Not for ophthalmic, oral, or intravaginal use. Not recommended for patients
under the age of 17 years. Not recommended for diaper dermatitis.
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: Avoid 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: FDA:
NDC: 0168-0370-30
0168-0370-60
M SDS# 04A Clotrimazole and Betamethasone Dipropionate Lotion, USP (August 9, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A white to off-white, smooth and homogeneous lotion with a slight waxy odor.
M olecular W eight: Not applicable.
pH: Approximately 5.0 - 6.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 2,000 - 4,500 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
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: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
Specific Gravity @ 25 o C: 0.85 - 1.05
% Volatile by Volume: Approximately 73% as water.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 0 Replaces
August 9, 2004 N/A
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 Clotrimazole and Betamethasone Dipropionate Lotion, USP (August 9, 2004) Page 4 of 4
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