MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Atropine Sulfate Ophthalmic Ointment USP, 1%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Pharmaceutical Ophthalmic Ointment
Formula: Atropine Sulfate, Lanolin, White Petrolatum, M ineral Oil, Purified W ater, and Chlorobutanol.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 2鈥?2 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 1鈥?2鈥?1 M oderate 2
Special Hazards: None indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. (Not applicable under standard Extreme 4
application.)
SECTION 3: EMERGENCY 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: Delay absorption by giving activated charcoal, then remove by gastric lavage. 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
Atropine Sulfate 5908-99-6 1.0 no no no not established
Lanolin 8006-54-0 no no no not established
White Petrolatum 8009-03-8 no no no not established
5mg/m3 * 5mg/m3 *
Mineral Oil 8042-47-5 yes yes no
not established
Water 7732-18-5 no no no
not established
Chlorobutanol 57-15-8 0.5 no no no
*as mist
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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
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid sources of heat, strong oxidizers, strong acids and bases.
Hazardous Combustion or Decomposition Products: M ay emit toxic fumes.
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. Depression, circulatory collapse, convulsions, respiratory failure.
b. Chronic Effects: b. Skin and Ingestion effects (see below)
1. Inhalation: 1. None expected under normal conditions of use.
2. Eyes: 2. None expected under normal conditions of use.
3. Skin: 3. Hot, dry, flushed, appearance of rash. Desquamation may occur.
4. Ingestion: 4. Dry mouth, burning sensation, marked thirst, blurred vision photophobia
5. M edical Conditions restlessness, disorientation, hallucination.
Potentially Aggravated: 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 Keep container closed when not in use. Avoid sources of heat, strong oxidizers, strong acids
Handling/Storage: and bases.
Hygienic Practices: W ash thoroughly after handling.
W hen M aterial is Released Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. W ash area
or Spilled: 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.
SECTION 9: SPECIAL PROTECTION INFORMATION
Respiratory Protection: Adequate general ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
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SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Avoid sources of heat, strong
oxidizers, strong acids and bases.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and sources of heat, strong oxidizers, strong acids
and bases.
Container Should be Handled in an Area with: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. (See package
insert.)
W arning Placard: Keep out of reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Avoid sources of heat, strong oxidizers, strong acids and bases.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0065-38
M SDS# 05A_Atropine Sulfate Ophthalmic Ointment USP, 1% (September 1, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A pale yellow, odorless ointment.
M olecular W eight: Not applicable.
pH: Not applicable.
Refractive Index @ 20 oC: Not indicated.
Viscosity: Not indicated.
W ater: 100 oC (212 oF), remainder at > 250 oC (480oF)
Boiling Point:
37oC (98.6 o)F
Freezing/M elting Point:
Congealing Point: Not indicated.
Vapor Pressure (mm Hg @ 20 oC): Not indicated.
Vapor Density (Air=1): Not indicated.
Solubility in W ater: Atropine Sulfate soluble, remainder insoluble.
Solubility in Alcohol: Partially soluble.
Solubility in Oil: Base soluble.
Solubility in Other: Not applicable.
Specific Gravity @ 25 oC: <1
% Volatile by Volume: < 10
Evaporation Rate (Ether=1): Not indicated.
Date of Preparation/Change: Revision # 3 Replaces
September 1, 2005 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 鈥? fax 973-663-2378
helpdesk@chemply.com
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