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MSDS Material Safety Data Sheet
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112-92-5
36653-82-4
9005-67-8
112-72-1
1338-41-6
5333-42-6
8042-47-5
100-51-6

File Name: fougera_com---1224.msds.asp
                                         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 Cream USP, 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: Not indicated. 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. 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


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 mo 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 Cream USP, 0.77% (February 25, 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.
Unusual Fire and Explosion Hazards: May 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 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: May cause skin irritation and allergic reaction in sensitive individuals.
b. Chronic Effects:
1. Inhalation: None expected under normal condition of use.
2. Eyes: Topical forms will cause moderate irritation. Not for ophthalmic use.
3. Skin: No effects expected under normal conditions of use.
4. Ingestion: May induce low toxicity.
5. Medical Conditions Skin conditions. Systemic effects may be produced.
Potentially Aggravated:


SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES

Keep container closed when not in use. Store at controlled room temperature 15O-30OC
Precautions to be Taken in
(59O -86O F). Avoid heat, light, oxidants and bases.
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.


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.




M SDS# 05A Ciclopirox Cream USP, 0.77% (February 25, 2005) Page 2 of 4
SECTION 10: CONTAINERS and LABELING

Keep container closed when not in use. Store at controlled room temperature 15O -30O C
Special Precautions:
(59O-86OF). 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 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 heat, light, oxidants and bases.


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: FDA:
NDC: 0168-0313-15
0168-0313-30
0168-0313-90




M SDS# 05A Ciclopirox Cream USP, 0.77% (February 25, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA

Appearance and Color: A white to off-white, smooth and homogeneous cream.
Molecular Weight: Not applicable.
pH: 5-8
Refractive Index @ 20O C: Not determined.
Viscosity: 45,000 - 200,000 cps
Boiling Point: Not determined.
Freezing/Melting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20O C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Disperses.
Specific Gravity @ 5OO C: ~ 0.94
% Volatile by Volume: ~ 63% 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 Cream USP, 0.77% (February 25, 2005) Page 4 of 4

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