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: Clindamycin Phosphate Gel USP, 1%
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Antibiotic.
Formula: Clindamycin Phosphate USP, Allantoin, Carbomer 934P NF, M ethyl Paraben NF, Polyethylene Glycol
400 NF, Propylene Glycol, Sodium Hydroxide 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: None required under standard application. 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 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
Clindamycin Phosphate 24729-96-2 1.0% no no no not established
Allantoin 97-59-6 no no no not established
Carbomer 934P 9003-01-4 no no no not established
Methyl Paraben 99-76鈥?3 no no no not established
Polyethylene Glycol 400 25322-68-3 no no no not established
Propylene Glycol 57-55-6 no no no not established
2mg/m3* 2mg/m3
Sodium Hydroxide 1310-73-2 no no no
Water 7732-18-5 no no no not established
not established
* ceiling
M SDS# 05A Clindamycin Phosphate Gel USP, 1% (September 30, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature NF: 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.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid sources of 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
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.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause nausea, vomiting, lethargy, diarrhea and colitis.
5. M edical Conditions 5. Colitis or hypersensitivity to any ingredients in preparation.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid sources of heat, light, oxidants and
Handling/Storage: bases. Store at 20N鈥?25NC (68N鈥?77N 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: 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 Gel USP, 1% (September 30, 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: Avoid sources of heat, light, oxidants and bases. Store at 20N鈥?25NC
(68N鈥?77N F). Protect from freezing.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Federal law prohibits dispensing without prescription. For external use only.
(See package insert.)
Container Should be Handled in an Area with: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: For external use only. Not for ophthalmic use. Do not use for children.
W arning Placard: Keep out of reach of children.
IM O Hazard Class #: No applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from sources of 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: FDA:
NDC: 0168-0202-30
0168-0202-60
M SDS# 05A Clindamycin Phosphate Gel USP, 1% (September 30, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A translucent, smooth and homogenous gel with a slight characteristic odor.
M olecular W eight: Not indicated.
pH: 4.5鈥?6.5
Refractive Index @ 20NC: Not determined.
Viscosity @ 25NC: 20,000鈥?60,000 cps
Boiling Point: ~ 100NC (212NF)
Freezing/M elting Point: Not applicable.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M iscible.
Solubility in Alcohol: Insoluble.
Solubility in Oil: Immiscible.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 0.95鈥?1.09 @ 25NC
% Volatile by Volume: ~ 60% (water)
Evaporation Rate (Ether=1): 0.16
Date of Preparation/Change: Revision # 3 Replaces
September 30, 2005 October 2, 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 Gel USP, 1% (September 30, 2005) Page 4 of 4
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