MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COM PANY
PHARM ADERM
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
Emergency Telephone No.: 631-454-7677
800-424-9300
SECTION 1: IDENTITY
Product Name: Puralube庐 Ointment
Synonyms: Petrolatum Ophthalmic Ointment. Sterile Ocular Lubricant
CAS #: Not applicable.
Chemical Family: Alkane.
Formula: Light mineral oil USP and White petrolatum USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 1 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0鈥?0鈥?3 Moderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EMERGENCY 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
0.2mg/m3 * 5mg/m3*
Light mineral oil 8012-95-1 no no no
White petrolatum 8009-03-8 no no no not established
* m ist
M SDS# 06A Puralube Ophthalmic Ointment (December 15, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature 潞F: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing Media: Alcohol foam, dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Wear protective clothing and self-contained breathing apparatus 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 Chemicals to Avoid: Avoid strong oxidizers and sources of heat.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. Generally non-toxic.
b. Chronic Effects: b. May produce allergic response in sensitive individuals, Carcinogenicity studies on highly refined
mineral oils (IARC Monographs Suppl. 7, 252, 1987) have been reviewed by IARC who found
that they 鈥渄o not permit an evaluation of its carcinogenicity.鈥?
1. Inhalation: 1. Not likely due to the physical state of the product..
2. Eyes: 2. May cause slight irritation.
3. Skin: 3. May cause slight irritation.
4. Ingestion: 4. Produces a mild laxative effect. Not absorbed but may inhibit the absorption of digestive
lipids.
5. Medical Conditions 5. May cause an allergic reaction 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. Store at room temperature. Avoid strong oxidizers and
Handling/Storage: sources of heat.
Hygienic Practices: Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
When Material is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash area
with soap and water. Dispose of in accordance with federal, state and local regulations.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at
approved incineration or chemical landfill waste disposal site.
SECTION 9: SPECIAL PROTECTION INFORMATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
M SDS# 06A Puralube Ophthalmic Ointment (December 15, 2006) Page 2 of 4
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Store at room temperature. Avoid strong oxidizers
and sources of heat.
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: None.
Warnings: Keep out of reach of children. Stop use and ask a doctor if you experience eye pain,
changes in vision, continued redness or irritation of the eye; if the condition worsens or
persists for more than 72 hours. Do not reuse. Once opened, discard.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from strong oxidizers and sources of heat.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 330.5
NDC: 0168-0150-11
0168-0150-38
M SDS# 06A Puralube Ophthalmic Ointment (December 15, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance: A white to off-white ointment, transparent in thin layers, with little-to-no odor.
Molecular Weight: Not applicable.
pH: Not determined.
Refractive Index @ 20潞C: Not determined.
Viscosity @ 25潞C: Not determined.
Boiling Point: >200潞C (>392潞F)
Freezing/Melting Point: ~56潞C (~133潞F)
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20潞C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Insoluble.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Soluble.
Solubility in Other: Not determined.
Specific Gravity (H2 O=1): 0.84@ 20潞C
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 0 Replaces
December 15, 2006 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. We 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 Material
Safety Data Sheet was prepared for ALTANA INC. by:
COMPLIANCE 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# 06A Puralube Ophthalmic Ointment (December 15, 2006) Page 4 of 4
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