SDS Number 3091 Approved/Revised 02-Mar-2006 Version 8
BACTROBAN CREAM
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material BACTROBAN CREAM
BACTROBAN CREAM 2% * NDC NO. 0029-1527-22 * NDC NO. 0029-1527-25
Synonyms
* CALCIUM MUPIROCIN, FORMULATED PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
CALCIUM MUPIROCIN DIHYDRATE 3
115074-43-6
NON-HAZARDOUS INGREDIENTS 97
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as a non-combustible solid and will not support
Fire and Explosion
propagating combustion.
* Health Caution - Pharmaceutical agent.
Exposure might occur via ingestion; skin; eyes.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the exposed subject is unconscious or semi-conscious. Wash
out the mouth with water. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.
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SDS Number 3091 Approved/Revised 02-Mar-2006 Version 8
BACTROBAN CREAM
Material
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment None.
Medical Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water is recommended for fires involving packaging.
Special Firefighting For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
corrosive or flammable vapours might be evolved from fires involving this
product and associated packaging, self contained breathing apparatus and
full protective equipment are recommended for firefighters.
If possible, contain and collect firefighting water for later disposal.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination Detergent solutions can be used for clean-up and decontamination
operations. No specific decontamination or detoxification procedures have
Procedures
been identified for this product.
7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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SDS Number 3091 Approved/Revised 02-Mar-2006 Version 8
BACTROBAN CREAM
Material
CALCIUM MUPIROCIN DIHYDRATE
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 5000 mcg/m3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
Other Equipment or Wash hands and arms thoroughly after handling. None required for normal
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Cream.
Physical Form
120 掳C (Closed Cup).
Flash Point
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Minor irritation might occur following direct contact with eyes.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects No adverse effects have been reported following extensive use or exposure
in humans.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: an
antibiotic.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
* Summary This material has had limited testing. There is insufficient information to
determine the scope of the environmental effects this material may cause.
Local regulations and procedures should be consulted prior to
environmental release.
ECOTOXICITY
Aquatic
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SDS Number 3091 Approved/Revised 02-Mar-2006 Version 8
BACTROBAN CREAM
Material
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphnids.
EC50: > 1000 mg/l, 48 Hours, Daphnia magna, Nominal
NOEL: 1000 mg/l
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only
authorised persons trained and competent in accordance with appropriate national and international
regulatory requirements may prepare dangerous goods for transport.
UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US
or European ground transport purposes.
15. REGULATORY INFORMATION
The information included below is an overview of the major regulatory requirements. It should not be
considered to be an exhaustive summary. Local regulations should be consulted for additional requirements.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 02-Mar-2006 SDS Version Number 8
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
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SDS Number 3091 Approved/Revised 02-Mar-2006 Version 8
BACTROBAN CREAM
Material
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Distribution
Earthworm
Ecotoxicity
Fish
GSK Environmental Hazard Category
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
HAZARDS IDENTIFICATION Health
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION US Environmental (EPA) Requirements
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate
as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the
responsibility of the user to determine the applicability of this information and the suitability of the material
or product for any particular purpose.
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