MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
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: Ciclopirox Topical Suspension USP (Lotion), 0.77%
Synonyms: None
CAS #: Mixture.
Chemical Family: Antifungal.
Formula: Stearyl Alcohol NF, Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF,
Octyldodecanol NF, Mineral Oil USP, Benzyl Alcohol NF, Lactic Acid USP 88%, Purified Water USP, Cocamide DEA,
Ciclopirox (as Ciclopirox Olamine) 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 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. 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
Stearyl Alcohol 112-92-5 no no no not established
Cetyl Alcohol 36653-82-4 no no no not established
Polysorbate 60 9005-67-8 no no no not established
Myristyl Alcohol 112-72-1 no no no not established
Sorbitan Monostearate 1338-41-6 no no no not established
Octyldodecanol 5333-42-6 no no no not established
Mineral Oil 8042-47-5 no no no not established
Benzyl Alcohol 100-51-6 no no no not established
Lactic Acid 50-21-5 no no no not established
Water 7732-18-5 no no no not established
Cocamide DEA 61791-31-9 no no no not established
Ciclopirox (as Ciclopirox Olamine) 41621-49-2 0.77% no no no not established
M SDS# 05A Ciclopirox Topical Suspension USP (Lotion), 0.77% (February 25, 2005) 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:
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:
b. Chronic Effects:
1. Inhalation: M ay cause allergic reaction and skin irritation.
2. Eyes: Not likely due to the physical state of the product.
3. Skin: M ay cause irritation. Not for ophthalmic use.
4. Ingestion: Not expected under normal conditions of usage.
5. M edical Conditions 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 between 5 o and 25 oC (41 o and 77F).
Precautions to be Taken in
Handling/Storage: Avoid heat, light, oxidants and bases.
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.
M SDS# 05A Ciclopirox Topical Suspension USP (Lotion), 0.77% (February 25, 2005) Page 2 of 4
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 between 5 o and 25 oC (41 o and 77 oF). Avoid heat,
Special Precautions:
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 dermatologic
use only. Not for use in eyes. (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: 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 references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 300.5
NDC: 0168-0314
M SDS# 05A Ciclopirox Topical Suspension USP (Lotion), 0.77% (February 25, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A white to off-white thick, smooth and homogeneous lotion.
M olecular W eight: Not applicable.
pH: 5.0 - 8.0
Refractive Index @ 20 OC: Not determined.
Viscosity @ 25 OC: 2,000 - 15,000 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.
Specific Gravity @ 25 O C: ~ 0.93
% Volatile by Volume: ~ 84% as water.
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 0 Replaces
February 25, 2005 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# 05A Ciclopirox Topical Suspension USP (Lotion), 0.77% (February 25, 2005) Page 4 of 4
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