M ATERIAL SAFETY D ATA SHEET

M anufacturer's Name: Divisions: ALTANA INC. 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: Synonyms: CAS #: Chemical Family: Formula: Puralube Ointment Petrolatum Ophthalmic Ointment. Sterile Ocular Lubricant Not applicable. Alkane. Light mineral oil USP and White petrolatum USP.

SECTION 2: SAFETY and HAZARD RATINGS Health (Acute-Chronic): Flammability: Reactivity: Environment (Air-Water-Soil): Special Hazards: Protective Equipment: 11 1 0 003 None. General ventilation, eye and hand wash. RATINGS Minimal Slight Moderate Severe Extreme

0 1 2 3 4

SECTION 3: EMERGENCY and FIRST AID PROCEDURES Eyes: Skin: Ingestion: Inhalation: Flush eyes with plenty of water for at least 15 minutes. Wash thoroughly with soap and water. Give two glasses of water and induce vomiting if directed by medical personnel. Never give anything by mouth to an unconscious person. 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 NAM E C A S# % IA R C NTP O SH A H A ZA R D D A T A A C G IH TLV O SH A PEL

Light mineral oil White petrolatum

8012-95-1 8009-03-8

no no

no no

no no

0.2mg/m3 * 5mg/m3* not established * m ist

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SECTION 5: FIRE and EXPLOSION HAZARD DATA Flash Point: Auto-ignition Temperature F: Flammable Limits in Air by Volume LEL: UEL: Extinguishing Media: Special Fire Fighting Procedures: Unusual Fire and Explosion Hazards: Not determined. Not determined. Not determined. Not determined. Alcohol foam, dry chemical, Carbon dioxide. Wear protective clothing and self-contained breathing apparatus when firefighting. Avoid mixing with strong oxidizers and sources of heat.

SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS) Stability: Conditions and Chemicals to Avoid: Hazardous Combustion or Decomposition Products: Hazardous Polymerization: [ X ] Stable [ ] Unstable

Avoid strong oxidizers and sources of heat. Carbon dioxide, Carbon monoxide. [ ] May Occur [ X ] Will Not Occur

SECTION 7: HEALTH HAZARDS Primary Route(s) of Entry: Signs and Symptoms of Exposure a. Overexposure Effects: b. Chronic Effects: Dermal, Ingestion. a. Generally non-toxic. 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 do not permit an evaluation of its carcinogenicity. 1. Not likely due to the physical state of the product.. 2. May cause slight irritation. 3. May cause slight irritation. 4. Produces a mild laxative effect. Not absorbed but may inhibit the absorption of digestive lipids. 5. May cause an allergic reaction in sensitive individuals.

1. 2. 3. 4.

Inhalation: Eyes: Skin: Ingestion:

5. Medical Conditions Potentially Aggravated:

SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES Precautions to be Taken in Handling/Storage: Hygienic Practices: When Material is Released or Spilled: Keep container closed when not in use. Store at room temperature. Avoid strong oxidizers and sources of heat. Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin. 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. Assure conformity with applicable disposal regulations. Dispose of absorbed material at approved incineration or chemical landfill waste disposal site.

Waste Disposal Methods:

SECTION 9: SPECIAL PROTECTION INFORMATION Respiratory Protection: Skin Protection: Eye Protection: Other Protective Clothing or Equipment: General ventilation. Normal hygiene. Normal hygiene. As needed to prevent repeated/prolonged contact.

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SECTION 10: CONTAINERS and LABELING Special Precautions: Recommended Container: Protect the Container by: Container Should be Handled in an Area With: The Empty Container is: Precautionary Label: Warnings: Keep container closed when not in use. Store at room temperature. Avoid strong oxidizers and sources of heat. As supplied (not sold in bulk quantity). Avoid physical damage and heat. Adequate, general ventilation. Not reusable. None. 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. Not applicable. Not applicable. Not applicable. Not applicable. Keep away from strong oxidizers and sources of heat.

IMO Hazard Class #: UN/NA #: Hazard Classification: DOT Name: Shipping Instructions:

SECTION 11: ENVIRONMENTAL RISKS Aquatic Toxicity: Biodegradability: Partition Coefficient: Not indicated. Not indicated. Not indicated.

SECTION 12: REGULATORY INFORMATION Refer to the following references: OSHA Regulations: DOT Regulations: EPA Regulations: Other: If respirator used, 29 CFR 1910.134 Not applicable. Not applicable. FDA: 21 CFR 330.5 NDC: 0168-0150-11 0168-0150-38

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SECTION 13: PHYSICAL DATA Appearance: Molecular Weight: pH: Refractive Index @ 20C: Viscosity @ 25C: Boiling Point: Freezing/Melting Point: Congealing Point: Vapor Pressure (mm Hg @ 20C): Vapor Density (Air=1): Solubility in Water: Solubility in Alcohol: Solubility in Oil: Solubility in Other: Specific Gravity (H2 O=1): % Volatile by Volume: Evaporation Rate (Ether=1): Date of Preparation/Change: December 15, 2006 A white to off-white ointment, transparent in thin layers, with little-to-no odor. Not applicable. Not determined. Not determined. Not determined. >200C (>392F) ~56C (~133F) Not determined. Not determined. Not determined. Insoluble. Partially soluble. Soluble. Not determined. 0.84@ 20C 0 0.00 Revision # 0 Replaces 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 fax 973-663-2378 helpdesk@chemply.com

M SDS# 06A Puralube Ophthalmic Ointment (December 15, 2006)

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