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 Topical Solution, 1%
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Antibiotic.
Formula: Clindamycin Phosphate, Isopropyl Alcohol, Propylene Glycol and W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-2 RATINGS
Flammability: 3 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-1 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. 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 applicable
Isopropyl Alcohol 67-63-0 50.0 no no no 200ppm 400ppm
Propylene Glycol 57-55-6 no no no not applicable
Water 7732-18-5 no no no not applicable
M SDS# 05A Clindamycin Phosphate Topical Solution, 1% (M arch 31, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
23.9 oC (75 oF)
Flash Point:
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.
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 bases, light, oxidants and sources of heat and flame.
Hazardous Combustion or Decomposition Products: M ay emit toxic fumes of Carbon Dioxide and Carbon M onoxide.
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 allergic reaction, nausea, intoxication, CNS depression, headache, decreased
blood rate, coma.
b. Chronic Effects b.
1. Inhalation: 1. M ay cause nausea, headache.
2. Eyes: 2. M ay cause irritation or injury.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause intoxication, CNS depression, headache, nausea, decreased blood
5. M edical Conditions rate, coma.
Potentially Aggravated: 5. M ay cause skin irritation and allergies in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Keep container closed when not in use. Store at controlled room temperature 15 oC鈥?
Precautions to be Taken in
30 oC (59 oF鈥?86 oF) and keep from freezing. Do not handle or store near bases, light,
Handling/Storage:
oxidants and sources of heat and flame.
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 Clindamycin Phosphate Topical Solution, 1% (M arch 31, 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. Store at controlled room
temperature 15 oC to 30 oC (59 oF to 86 oF) and keep from freezing. Do not
handle or store near bases, light, oxidants and sources of heat and flame.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, heat and freezing temperatures.
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. Not for ophthalmic
use.
W arning Placard: Flammable liquid. Keep out of the reach of children.
IM O Hazard Class #: 9
UN/NA #: Not applicable.
Hazard Classification: ORM -D
DOT Name: Consumer Commodity
Shipping Instructions: Keep away from bases, light, oxidants and sources of heat and flame.
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: 49 CFR 172.101
EPA Regulations: SARA Title III, Section 311/312, Health (Immediate) and Flammable
Other: NDC: 0168-0201-30
0168-0201-60
M SDS# 05A Clindamycin Phosphate Topical Solution, 1% (M arch 31, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A clear, colorless solution with an odor of isopropyl alcohol.
M olecular W eight: Not applicable.
pH: 4.0鈥?7.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
Refluxes @ 55 oC (131 oF)
Boiling Point:
Freezing/M elting Point: Not determined.
Congealing Point: Not applicable.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M iscible.
Solubility in Alcohol: M iscible.
Solubility in Oil: Immiscible.
Solubility in Other: Not determined.
0.93 @ 25 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: 50% (v/v) isopropyl alcohol
Evaporation Rate (Ether=1): 0.26
Date of Preparation/Change: Revision # 3 Replaces
M arch 31, 2005 M arch 3, 2005
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 w hether 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 Topical Solution, 1% (M arch 31, 2005) Page 4 of 4
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