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: Clindamycin Phosphate Lotion
Synonyms: Clindamycin Phosphate Topical Suspension USP, 1%
CAS #: Not applicable.
Chemical Family: Antibacterial.
Formula: Clindamycin Phosphate USP, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate SE (with Potassium
M onostearate), Isostearyl Alcohol, M ethylparaben, Sodium Lauroyl Sarcosinate, Stearic Acid and
Purified W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 1鈥?1鈥?1 M oderate 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: 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
Clindamycin Phosphate 24729-96-2 1.0 no no no not established
Cetostearyl Alcohol 8005-44-5 2.5 no no no not established
Glycerin 56-81-5 no no no not established
Glyceryl Stearate SE (with Potassium Monostearate) 31566-31-1 no no no 10 mg/m3* not established
Isostearyl Alcohol 27458-93-1 2.5 no no no not established
Methylparaben 99-76-3 no no no not established
Sodium Lauroyl Sarcosinate 137-16-6 0.3 no no no not established
Stearic Acid 57-11-4 no no no not established
Water 7732-18-5 no no no not established
*as stearate
M SDS# 05A Clindamycin Phosphate Lotion (June 6, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature oF: Not applicable.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning, and may react with bases and oxidizers.
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: 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 eye, skin and/or respiratory irritation.
b. Chronic Effects b. Possible hypersensitization.
1. Inhalation: 1. M ay cause nausea, irritation to respiratory system.
2. Eyes: 2. M ay cause irritation. Avoid contact with eyes.
3. Skin: 3. Prolonged contact may cause irritation.
4. Ingestion: 4. M ay cause diarrhea/bloody diarrhea, severe colitis.
5. M edical Conditions 5. Respiratory and skin conditions. Hypersensitivity to preparation. Antibiotic-
Potentially Aggravated: associated colitis.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not handle or store near heat, light,
oxidants and bases. Store at 20 o鈥?25 oC (68 o鈥?77 oF). Protect from freezing.
Handling/Storage:
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 Clindamycin Phosphate Lotion (June 6, 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 closed when not in use. Do not handle or store near heat,
light, oxidants or bases. Store at 20 o鈥?25 oC (68 o鈥?77 oF). Protect from freezing.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, heat and light.
Container Should be Handled in an Area with: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without prescription. For external use only.
Avoid contact with 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: 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: 0168-0203-60
M SDS# 05A Clindamycin Phosphate Lotion (June 6, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance (and Odor): A white to off-white lotion with no discernible odor.
M olecular W eight: Not applicable.
pH: 4.5鈥?6.5
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 200鈥?7,500 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.
Solubility in Alcohol: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
0.95鈥?1.02 @ 25 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: ~ 85% (water)
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
June 6, 2005 M ay 10, 2002
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 Clindamycin Phosphate Lotion (June 6, 2005) Page 4 of 4
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