Microsoft word - prilosec otc 12-17-07.doc

MATERIAL SAFETY DATA SHEET
Prilosec OTC™ Tablets
Page 1 of 4
SECTION I – CHEMICAL / PRODUCT AND COMPANY IDENTIFICATION
THE PROCTER & GAMBLE COMPANY
Hazard Rating
EMERGENCY PHONE:
Transportation Emergency (24 hour) Telephone Number: CHEMTREC: 1-800-424-9300 in the U.S. and Canada; Issue Date: December 17, 2007 Last Reviewed: 09/09/2003 1-703-527-3887 for calls originating elsewhere or call the Poison Control Center Material Name:
Prilosec OTC™ Tablets
SECTION II – COMPOSITION AND INGREDIENTS
Hazardous ingredients as defined by OSHA, 29 CFR 1910.1200, and/or WHMIS under the HPA. These substances are
listed because in their pure bulk form, they meet the OSHA definition of hazardous. Any hazards associated with this
finished product are listed in Section III of this MSDS.
Principal Hazardous Components: CAS
Exposure Limit/
LC50/LD50
Omeprazole magnesium
95382-33-5
0.5 mg/m3 (Internal
Exposure Guideline)
SECTION III – HAZARDS IDENTIFICATION
Emergency Overview: As a result of the physical presentation of the product, the risk to health in the
normal handling of the product is expected to be low. When bulk unpackaged product is handled, there
may be a risk. Please refer to the information in this Material Data Safety Sheet. This mixture is a product
regulated by the FDA. Within the meaning of the OSHA Hazard Communication Standard [29 CFR
1910.1200]: this mixture is not considered a hazard when used in a manner which is consistent with the
labeled directions.
Eye: May cause eye irritation. May cause conjunctivitis.
Skin: By analogy with a similar substance this material is likely to be a skin sensitizer. May
cause sensitization by skin contact.
Inhalation: Dust may be irritant to the respiratory tract. Higher concentrations may cause nausea
and vomiting.
Ingestion: Adverse effects similar to inhalation may occur. Oral Median Lethal Dose (rat) > 2,000
Procter & Gamble

PROCTER & GAMBLE Page 2 of 4
MSDS Identifier: Prilosec OTC™ Tablets
SECTION IV – FIRST AID MEASURES
Eye: Irrigate with eyewash solution or clean water, holding the eyelids apart, for at least 15
minutes. Obtain medical attention.
Skin: Remove contaminated clothing. Wash skin with soap and water. If symptoms (irritation or
blistering) occur, obtain medical attention.
Inhalation: Remove patient from exposure. Obtain medical attention if ill effects occur.
Ingestion: Wash out mouth with water and give 200-300 mls of water to drink. Obtain medical
attention if ill effects occur.
Additional First Aid Measures: Note to Physician: Symptomatic treatment and supportive therapy as
indicated. For further detail, consult the prescribing information.
SECTION V – FIRE FIGHTING MEASURES
Flash Point: Not applicable
Flash Point test
Not applicable
Auto-ignition
Not applicable
Not available Flammable Limits
Temperature:
(% by volume in air)
Extinguishing Media: Use water spray, alcohol foam, or carbon dioxide.
Explosion Hazards: Combustible dust if not in tablet form.
Special Instructions: This product may form flammable dust clouds in the air, if dust from tablets is
allowed to accumulate and if it is dispersed.
SECTION VI – ACCIDENTAL RELEASE MEASURES
Personal Safeguards: Ensure suitable personal protection during removal of spillages. Ensure
adequate ventilation.
Environmental Dispose in accordance with all regulations.
Precautions:
Spill Clean-up Household: Safe to dispose of in refuse.
Procedures: Industrial Setting: Ensure suitable personal protection during removal of
spillages. Ensure adequate ventilation. In case of accident, avoid breathing
dust from crushed tablets. Transfer spilled tablets to a suitable container for
disposal. Wash the spillage with water.
SECTION VII – HANDLING AND STORAGE
Recommended Storage Temperature: Store at room temperature.
Personal No special precautions are necessary when handling packed product. The handling of
Precautions for unpackaged product may require precautions. Avoid contact with skin and eyes.
Safe Storage and Atmospheric levels should be controlled in compliance with the occupational exposure
Handling: limit. Follow procedures specified in the National Fire Protection Associated Codes
and Standards for handling combustible dusts (or explosive dusts).
Conditions for Keep container tightly closed. Keep out of reach of children.
Safe Storage:
Other None
Precautions:
SECTION VIII – EXPOSURE CONTROLS, PERSONAL PROTECTION
This section only applies to the product when used in an industrial setting.
Ventilation: Local exaust ventilation may be needed for control.
Eye Protection: Chemical tight goggles
Respiratory Protection: If needed, use a NIOSH approved respirator when there is a potential to be
above the safe exposure limit. For bulk handling of this material NIOSH
approved air supplied respirator with hoods are recommended.
Skin Protection: Impervious gloves and apron.
Other Special Protection: Eyewash station and safety shower in work area.
Procter & Gamble

PROCTER & GAMBLE Page 3 of 4
MSDS Identifier: Prilosec OTC™ Tablets
SECTION IX – PHYSICAL AND CHEMICAL PROPERTIES
Appearance / Color: Pink tablet
Melting Point: Not available
Odor: Not
available
Point: Not
available
Odor Threshold: Not available
Solubility in Not available
Physical State: Solid
Vapor Pressure
(mm Hg): Not applicable
Vapor Density: Not applicable
Specific Gravity Not applicable
(H2O=1):
pH: Not available
Other Data: Product complies with State
and Federal regulations for
VOC content.
SECTION X – STABILITY AND REACTIVITY
Stability: Stable
Possibility of Hazardous Hazardous polymerization will not occur.
Reaction:
Incompatibility: None known
(Materials to avoid)
Hazardous None known
Decomposition Products:
SECTION XI – TOXICOLOGICAL INFORMATION
Chronic Effects: Ingestion studies in animals have shown that repeated doses produce adverse
effects on the kidney and gastrointestinal tract.
Target Organs: Ingestion studies in animals have shown that repeated doses produce adverse
effects on the kidney and gastrointestinal tract.
Carcinogenicity: Short term tests have shown that it is unlikely to be a carcinogenic hazard to
NTP: No
SECTION XII – ECOLOGICAL INFORMATION
Relevant ecotoxicity and fate data for ingredients in this formulation have been reviewed. Under normal
and foreseeable consumer uses, there are no concerns for aquatic organisms exposed to product ingredients
at the anticipated environmental concentrations. The product is compatible with down-the-drain disposal
routes, including municipal wastewater treatment processes and septic tank systems. This product is
intended for dispersive use and should not be disposed of directly into the environment.
Procter & Gamble

PROCTER & GAMBLE Page 4 of 4
MSDS Identifier: Prilosec OTC™ Tablets
SECTION XIII – DISPOSAL CONSIDERATIONS
Waste Disposal Method: Disposal is to be performed in compliance with Federal, State/Provincial and Local
regulations.
SECTION XIV – TRANSPORTATION
Agency Classification
US DOT (transportation by Non-Regulated
ground)
IMDG (transportation by
Non-Regulated
IATA (transportation by
Non-Regulated
SECTION XV – ADDITIONAL REGULATORY INFORMATION
The product(s) described in this Material Safety Data Sheet are regulated under the Federal Food, Drug and
Cosmetics Act and are safe to use as per directions on container, box or accompanying literature (where
applicable).
US Federal:

TSCA – All intentionally-added components of this product are listed on the US TSCA Inventory.
SARA 313/302/304/311/312 chemicals: None

US States:
California: This product has been evaluated and does not require warning labeling under California
Proposition 65.
California Registration Number: None
State Right-to-Know and CERCLA: The following ingredients present in the finished product are listed on
state right-to-know lists or state work exposure lists.
Ingredient(s) CERCLA
RQ State(s)
Not applicable
Not applicable Not
applicable
SECTION XVI – OTHER INFORMATION
DISCLAIMER: This MSDS is intended to provide a brief summary of our knowledge and guidance regarding the
use of this material. The information contained here has been compiled from sources considered by Procter &
Gamble to be dependable and is accurate to the best of the Company’s knowledge. It is not meant to be an all-
inclusive document on worldwide hazard communication regulations.
This information is offered in good faith. Each user of this material needs to evaluate the conditions of use and
design the appropriate protective mechanisms to prevent employee exposures, property damage or release to the
environment. Procter & Gamble assumes no responsibility for injury to the recipient or third persons, or for any
damage to any property resulting from misuse of the product.

Source: http://www.menards.com/msds/111329_001.pdf