MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO.
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: Metronidazole Topical Lotion, 0.75%
Synonyms: None indicated.
CAS #: None indicated.
Chemical Family: Antibacterial.
Formula: Metronidazole USP, Benzyl alcohol NF, Carbomer 941 NF, Cyclomethicone, Glycerin USP, Glyceryl stearate, Light
mineral oil NF, PEG 100 Stearate, PEG 400NF, Potassium sorbate NF, Purified water USP, Steareth-21, Stearyl
alcohol NF, Sodium hydroxide NF, and Lactic acid 88% USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0鈥?1鈥?1 Moderate 2
Special Hazards: None. 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: 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
M etronidazole 443-48-1 0.75 yes yes no not established
B enzyl alcohol 100-51-6 no no no not established
C arbom er 941 9003-01-4 no no no not established
C yclom ethicone 69430-24-6 no no no not established
G lycerin 56-81-5 no no no 10m g/m 3 not established
G lyceryl stearate 123-94-4 no no no 10m g/m 3* not established
L ight m ineral oil 8012-95-1 yes yes no 0.2m g/m 3 not established
P E G 100 stearate 9004-99-3 no no no 20m g/m 3* not established
P E G 400 25322-68-3 no no no not established
P otassium sorbate 24634-61-5 no no no not established
W ater 7732-18-5 no no no not established
Steareth-21 9005-00-9 no no no not established
Stearyl alcohol 112-92-5 no no no not established
Sodium hydroxide 1310-73-2 no no no not established
L actic acid 50-21-5 no no no *stearates
M SDS# 05A M etronidazole Topical Lotion, 0.75% (November 7, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature 潞F: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and full protective clothing.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes in a fire.
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 Products: M ay emit toxic fumes (Carbon dioxide, Carbon monoxide).
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause irritation, metallic taste, tingling or numbness of extremities, or nausea.
b. Chronic Effects b. M ay cause reproductive effects.
1. Inhalation: 1. M ay cause nausea.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation, metallic taste, tingling or numbness of extremities, or nausea.
4. Ingestion: 4. M ay cause nausea.
5. M edical Conditions 5. Blood dyscrasia. M ay cause skin irritation and allergies in individuals sensitive to
Potentially Aggravated: any ingredients.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container tightly closed when not in use. Avoid heat, light, oxidants and bases.
Handling/Storage: Store at controlled room temperature 20潞鈥?25潞C (68潞鈥?77潞F). Protect from freezing.
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: Avoid any ignition sources. Use non-sparking tools. Absorb on sand or vermiculite
and place in closed containers for disposal. Ventilate and wash area after material
pickup is complete, Report major leaks and spills to the appropriate local, state
and/or federal governmental agency.
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 M etronidazole Topical Lotion, 0.75% (November 7, 2005) 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 tightly closed when not in use. Avoid heat, light, oxidants and
bases. Store at controlled room temperature 20潞鈥?25潞C (68潞鈥?77潞F). Protect
from freezing.
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: Adequate 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. (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. Protect from freezing.
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: 0168-0383-60
M SDS# 05A M etronidazole Topical Lotion, 0.75% (November 7, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A translucent, white to off-white, smooth and homogeneous lotion.
M olecular W eight: Not applicable.
pH: ~5
Refractive Index @ 20潞C: Not determined.
Viscosity @ 25潞C: 2,000鈥?8,000 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20潞C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Disperses.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Solubility in Other: Not indicated.
Specific Gravity (H 2O=1): ~ 1@ 25潞C
% Volatile by Volume: ~ 70% as water
Evaporation Rate (Ether=1): Not indicated.
Date of Preparation/Change: Revision # 0 Replaces
November 7, 2005 None
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 etronidazole Topical Lotion, 0.75% (November 7, 2005) Page 4 of 4
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