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: Surgilube
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Pharmaceutical lubricant.
Formula: W ater, Propylene Oxide, Chlorhexidine Gluconate 20% , Acetic Acid, Lavender, Propylene Glycol,
Hydroxypropyl M ethylcellulose, Polypropylene Glycol, and Sodium Acetate.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-0 M oderate 2
Special Hazards: None indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush immediately 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
Water 7732-18-5 no no no not established
Propylene Oxide 75-56-9 <0.025 yes yes yes 2ppm 100ppm
Chlorhexidine Gluconate 20% 18472-51-0 no no no not established
Acetic Acid 64-19-7 no no no 10ppm 10ppm
Lavender n/a no no no not established
Propylene Glycol 57-55-6 no no no not established
Hydroxypropyl Methylcellulose 9004-65-3 no no no not established
Polypropylene Glycol 25322-69-4 no no no not established
Sodium Acetate 6131-90-4 no no no not established
M SDS# 04A Surgilube (November 11, 2004) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
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, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing when
firefighting.
Unusual Fire and Explosion Hazards: Avoid mixing with strong oxidizers and sources of heat.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Avoid heat, flame and oxidizers.
Chemicals to Avoid:
Hazardous Combustion or M ay emit toxic fumes of carbon when burned (CO, CO 2).
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. Practically non-toxic.
b. Chronic Effects: b. M ay produce allergic reactions in sensitive individuals.
IARC: Propylene Oxide (Vol 60; 1994).
NTP: There is clear evidence in mice and some evidence in rats of Propylene Oxide鈥檚
carcinogenicity (NTP-TR-267,85).
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. M ay cause slight irritation.
3. Skin: 3. None expected under normal conditions of use.
4. Ingestion: 4. M ay cause mild nausea and/or vomiting.
5. M edical Conditions 5. Irritation of the skin in sensitive individuals.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid heat, flame and oxidizers.
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 unless
thoroughly laundered.
W hen M aterial is Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove to
Released or Spilled: plastic-lined fiber containers immediately. 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# 04A Surgilube (November 11, 2004) 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. Avoid heat, flame and oxidizers.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoiding physical damage and heat.
Container Should be Handled in an Area with: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: None.
W arning Placard: None.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from heat, flame and oxidizers.
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: 21CFR 330.5
NDC: 0168-0205-02
0168-0205-06
0168-0205-12
0168-0205-36
0168-0205-37
0168-0205-43
0168-0205-45
0168-0205-55
M SDS# 04A Surgilube (November 11, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A smooth, translucent gel with a slight odor of lavender.
M olecular W eight: Not determined.
pH: 4.0 - 7.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 150- 1000 P
100 oC (212. oF)
Boiling Point:
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: Disperses.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
1.0 @ 20 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: Approximately 85
Evaporation Rate (Ether=1): 0.02
Date of Preparation/Change: Revision # 2 Replaces
November 11, 2004 December 8, 2000
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# 04A Surgilube (November 11, 2004) Page 4 of 4
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