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									MATERIAL SAFETY DATA SHEET
Manufacturer's Name: Divisions: Street Address: City, State, Zip Code: Emergency Telephone No.: ALTANA INC. E. FOUGERA & CO. DIVISION PHARMADERM DIVISION 60 BAYLIS ROAD MELVILLE, NEW YORK 11747 (631) 454-7677

SECTION 1: IDENTITY Product Name: Synonyms: CAS #: Chemical Family: Formula: Atropine Sulfate Ophthalmic Ointment USP, 1% None. Not applicable. Pharmaceutical Ophthalmic Ointment Atropine Sulfate, Lanolin, White Petrolatum, M ineral Oil, Purified W ater, and Chlorobutanol.

SECTION 2: SAFETY and HAZARD RATINGS Health (Acute-Chronic): Flammability: Reactivity: Environment (Air-W ater-Soil): Special Hazards: Protective Equipment: 2–2 0 0 1–2–1 None indicated. General ventilation, eye and hand wash. (Not applicable under standard application.) RATINGS M inimal Slight M oderate 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. W ash thoroughly with soap and water. Delay absorption by giving activated charcoal, then remove by gastric lavage. 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

Atropine Sulfate Lanolin White Petrolatum Mineral Oil Water Chlorobutanol

5908-99-6 8006-54-0 8009-03-8 8042-47-5 7732-18-5 57-15-8

1.0

0.5

no no no yes no no

no no no yes no no

no no no no no no

not established not established not established
5mg/m3 * 5mg/m3 *

not established not established *as mist

M SDS# 05A_Atropine Sulfate Ophthalmic Ointment USP, 1% (September 1, 2005)

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SECTION 5: FIRE and EXPLOSION HAZARD DATA Flash Point: Auto-ignition Temperature oF: Flammable Limits in Air by Volume LEL: UEL: Extinguishing M edia: Special Fire Fighting Procedures: Unusual Fire and Explosion Hazards: Not indicated. Not indicated. Not indicated. Not indicated. Alcohol foam, Dry chemical, Carbon dioxide Use self-contained breathing apparatus. M ay emit toxic fumes.

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

Avoid sources of heat, strong oxidizers, strong acids and bases. M ay emit toxic fumes. [ ] M ay Occur [ X ] W ill Not Occur

SECTION 7: HEALTH HAZARDS Primary Route(s) of Entry: Signs and Symptoms of Exposure a. Overexposure Effects: b. Chronic Effects: 1. Inhalation: 2. Eyes: 3. Skin: 4. Ingestion: 5. M edical Conditions Potentially Aggravated: Dermal, Ingestion. a. Depression, circulatory collapse, convulsions, respiratory failure. b. Skin and Ingestion effects (see below) 1. None expected under normal conditions of use. 2. None expected under normal conditions of use. 3. Hot, dry, flushed, appearance of rash. Desquamation may occur. 4. Dry mouth, burning sensation, marked thirst, blurred vision photophobia restlessness, disorientation, hallucination. 5. Skin irritation and allergy in sensitive individuals. Difficulty emptying bladder completely, glaucoma, gastrointestinal effects.

SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES Precautions to be Taken in Handling/Storage: Hygienic Practices: W hen M aterial is Released or Spilled: W aste Disposal M ethods: Keep container closed when not in use. Avoid sources of heat, strong oxidizers, strong acids and bases. W ash thoroughly after handling. 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. 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: Skin Protection: Eye Protection: Other Protective Clothing or Equipment: Adequate general ventilation. Normal hygiene. Normal hygiene. As needed to prevent repeated/prolonged contact.

M SDS# 05A_Atropine Sulfate Ophthalmic Ointment USP, 1% (September 1, 2005)

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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: W arning Placard: IM O Hazard Class #: UN/NA #: Hazard Classification: DOT Name: Shipping Instructions: Keep container closed when not in use. Avoid sources of heat, strong oxidizers, strong acids and bases. As supplied (not sold in bulk quantity). Avoid physical damage and sources of heat, strong oxidizers, strong acids and bases. Adequate general ventilation. Not reusable. Federal law prohibits dispensing without a prescription. (See package insert.) Keep out of reach of children. Not applicable. Not applicable. Not applicable. Not applicable. Avoid sources of heat, strong oxidizers, strong acids and bases.

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. NDC: 0168-0065-38

M SDS# 05A_Atropine Sulfate Ophthalmic Ointment USP, 1% (September 1, 2005)

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SECTION 13: PHYSICAL DATA Appearance and Odor: M olecular W eight: pH: Refractive Index @ 20 oC: Viscosity: Boiling Point: Freezing/M elting Point: Congealing Point: Vapor Pressure (mm Hg @ 20 oC): Vapor Density (Air=1): Solubility in W ater: Solubility in Alcohol: Solubility in Oil: Solubility in Other: Specific Gravity @ 25 oC: % Volatile by Volume: Evaporation Rate (Ether=1): Date of Preparation/Change: September 1, 2005 A pale yellow, odorless ointment. Not applicable. Not applicable. Not indicated. Not indicated. W ater: 100 oC (212 oF), remainder at > 250 oC (480oF) 37oC (98.6 o)F Not indicated. Not indicated. Not indicated. Atropine Sulfate soluble, remainder insoluble. Partially soluble. Base soluble. Not applicable. <1 < 10 Not indicated. Revision # 3 Replaces September 18, 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 • fax 973-663-2378 helpdesk@chemply.com

M SDS# 05A_Atropine Sulfate Ophthalmic Ointment USP, 1% (September 1, 2005)

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