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: M iconazole Nitrate Cream USP, 2% .
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Pharmaceutical Cream
Formula: M iconazole Nitrate 2% , M ineral Oil, Pegoxyl 7 Stearate, Peglicol 5 Oleate, Butylated Hydroxyanisole,
Benzoic Acid, and W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 2-1 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-1 M oderate 2
Special Hazards: None indicated. 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 as 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
Miconazole Nitrate 22832-87-7 2% no no no not established
.2mg/m3 5mg/m3*
Mineral Oil 8012-95-1 no no no
10mg/m 3** not established
Pegoxyl 7 Stearate N/A no no no
Peglicol 5 Oleate N/A no no no not established
Butylated Hydroxyanisole 25013-16-5 no no no not established
Benzoic Acid 65-85-0 no no no not established
Water 7732-18-5 >50% no no no not established
*as m ist **as stearate
M SDS# 05A _M iconazole Nitrate Cream USP, 2% (M arch 2, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
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 and 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.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid oxidizers, sources of heat, flame and bases.
Hazardous Combustion or Decomposition Products: Unlikely under normal room temperature storage.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should 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 irritation, vomiting, diarrhea, convulsions, heart rhythm disorders.
b. Chronic Effects: b. Possible hypersensitization.
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause vomiting, diarrhea, convulsions, heart rhythm disorders.
5. M edical Conditions 5. Hypersensitivity to any of the ingredients.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store between 15 o and 30 oC (59 oF and 86 oF)
Precautions to be Taken in
Handling/Storage: and away from 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.
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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. Keep away from sources of heat, flame
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: Cool, dry conditions.
The Empty Container is: Not reusable.
Precautionary Label: Do not use on children under 2 years of age. For external use only. Not for
ophthalmic use. (See package insert.)
W arning Placard: Keep out of the reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from sources of heat, flame 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: 21CFR 330
NDC: 0168-0142-31
M SDS# 05A _M iconazole Nitrate Cream USP, 2% (M arch 2, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white cream with a slight odor.
M olecular W eight: Not applicable.
pH: Not applicable.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
100 oC (212 oF)
Boiling Point:
50 oC (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: M ostly soluble.
Solubility in Oil: Slightly soluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 0.94 - 1.03
% Volatile by Volume: >50 (water)
Evaporation Rate (Ether=1): 0.08
Date of Preparation/Change: Revision # 3 Replaces
M arch 2, 2005 November 30, 1993
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 _M iconazole Nitrate Cream USP, 2% (M arch 2, 2005) Page 4 of 4
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