MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. 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 etronidazole Topical Cream, 0.75%
Synonyms: None.
CAS #: M ixture.
Chemical Family: Antifungal.
Formula: M etronidazole USP, Emulsifying W ax, Sorbitol Solution, Glycerin, Isopropyl Palmitate, Benzyl Alcohol,
Lactic Acid, Purified Water and/or Sodium Hydroxide to adjust pH.
SECTION 2: SAFETY and HAZARD RATINGS
RATINGS
Health (Acute-Chronic): 1鈥?1
Minimal 0
Flammability: 1
Slight 1
Reactivity: 0
Moderate 2
Environment (Air-W ater-Soil): 0鈥?1鈥?1
Severe 3
Special Hazards: Not indicated.
Extreme 4
Protective Equipment: General ventilation, eye and hand wash.
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 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
Metronidazole 443-48-1 0.75 yes yes no not established
Emulsifying Wax n/a no no no not established
Sorbitol Solution 50-70-4 no no no not established
Glycerin 56-81-5 no no no not established
Isopropyl Palmitate 142-91-6 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
Sodium Hydroxide 1310-73-2 no no no not established
M SDS# 06A M etronidazole Topical Cream, 0.75% (M arch 31, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature NF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
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 skin irritation and allergic reaction in sensitive individuals.
b. Chronic Effects:
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. Topical forms will cause moderate irritation. Not for ophthalmic use.
3. Skin: 3. None expected under normal conditions of use.
4. Ingestion: 4. M ay induce low toxicity.
5. M edical Conditions 5. Skin conditions. Systemic effects may be produced.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Store at controlled room temperature
Handling/Storage: 15N鈥?30NC (59N鈥?86NF). 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# 06A M etronidazole Topical Cream, 0.75% (M arch 31, 2006) Page 2 of 4
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. Store at controlled room
temperature 15N鈥?30NC (59N鈥?86NF). 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 W ith: General ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For topical use
only (not for ophthalmic use).
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: Keep away from 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: NDC: 0168-0323-46
M SDS# 06A M etronidazole Topical Cream, 0.75% (M arch 31, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A white-to-slightly yellow, smooth and homogeneous cream.
M olecular W eight: Not applicable.
pH: 4.0 鈥? 6.0
Refractive Index @ 20NC: Not determined.
Viscosity CPS @ 25NC: 25,000 - 125,000 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Disperses.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Specific Gravity @ 50NC: ~ 0.94
% Volatile by Volume: 68% as water
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
M arch 31, 2006 M arch 21, 2003
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# 06A M etronidazole Topical Cream, 0.75% (M arch 31, 2006) Page 4 of 4
|