SDS Number 110582 Approved/Revised 23-Mar-2007 Version 10
TEMOVATE CREAM
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material TEMOVATE CREAM
TEMOVATE CREAM, 0.05% * DERMOVATE CREAM, 0.05% * DERMOVATE
Synonyms
CREMA * DERMOVATE CREME * DERMOVATE KREM * DERMOVATE
KREMS * PSOREX CREAM * NDC NO 59075-375-73 * NDC NO 59075-375-72
* NDC NO 59075-375-01 * NDC NO 59075-375-02 * CLOBETASOL
PROPIONATE, 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
CLOBETASOL PROPIONATE 0.05
25122-46-7
NON-HAZARDOUS INGREDIENTS 99.95
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Potent pharmaceutical agent.
Health effects information is based on hazards of components.
May cause steroid withdrawal rash.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
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SDS Number 110582 Approved/Revised 23-Mar-2007 Version 10
TEMOVATE CREAM
Material
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.
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 Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of glucocorticosteroid.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
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, corrosive or
Procedures
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 No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
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.
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SDS Number 110582 Approved/Revised 23-Mar-2007 Version 10
TEMOVATE CREAM
Material
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
CLOBETASOL PROPIONATE
INGREDIENT
4
GSK Occupational
Hazard Category
SKIN
GSK Occupational 2 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.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Cream.
Physical Form
4.7 to 5.7
pH of Aqueous Solutions
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. Pharmacological effects
may occur following skin absorption.
Eye Effects Minor irritation might occur following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: adrenal glands; immune system.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon information from human exposure.
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 Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This material is a selective glucocorticoid receptor agonist.
Adverse effects of overexposure might include: suppression of adrenal
glands; temporary decrease in white blood cell counts; symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing);
increased susceptibility to infection.
Other Adverse Effects None known for occupational exposure.
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SDS Number 110582 Approved/Revised 23-Mar-2007 Version 10
TEMOVATE CREAM
Material
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no environmental effects have been identified. This material
contains an active pharmaceutical ingredient that may persist in the
environment. Local regulations and procedures should be consulted prior to
environmental release.
Specific information on the active pharmaceutical ingredient is provided
below.
ECOTOXICITY
Aquatic
Activated Sludge This material is not toxic to activated sludge microorganisms.
Respiration IC50: > 100 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 100 mg/l, 3 Hours
Algal This material contains an active pharmaceutical ingredient that is not toxic
to algae.
IC50: > 4.2 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Measured
NOEL: 1.3 mg/l, 72 Hours
Daphnid No toxicity to daphnids was observed for the active pharmaceutical
ingredient in this mixture, but the upper range of the test was limited by the
low water solubility of this compound.
EC50: > 1.4 mg/l, 48 Hours, Daphnia magna, Measured
NOEL: 1.4 mg/l, 48 Hours
Fish No toxicity to fish was observed for the active pharmaceutical ingredient,
but the upper range of the test was limited by the low water solubility of the
compound.
Juvenile Oncorhyncus mykiss, rainbow trout
EC50: > 0.75 mg/l, 96 Hours, Measured
NOEL: 0.75 mg/l, 96 Hours
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable (as defined by 1993 OECD Testing Guidelines). It
may persist in the environment.
Aerobic - Inherent
Percent Degradation: < 5 %, 14 days, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
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.
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SDS Number 110582 Approved/Revised 23-Mar-2007 Version 10
TEMOVATE CREAM
Material
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.
For waste disposal purpose, this product should be classified in line with the European Waste Catalogue
criteria.
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 23-Mar-2007 SDS Version Number 10
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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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