SDS Number 127730 Approved/Revised 12-Jul-2004 Version 05
Material ALPHOSYL HC CREAM
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ALPHOSYL HC CREAM
FORMULA NUMBER IB-0532 * ALLANTOIN, COAL TAR EXTRACT AND
Synonyms
HYDROCORTISONE ALCOHOL, 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
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 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
COAL TAR EXTRACT 5
8007-45-2
ALLANTOIN 2
97-59-6
HYDROCORTISONE 0.54
50-23-7
NON-HAZARDOUS INGREDIENTS 92.46
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Handling this product in its final form presents minimal risk from
occupational exposure.
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
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SDS Number 127730 Approved/Revised 12-Jul-2004 Version 05
Material ALPHOSYL HC CREAM
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 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 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.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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SDS Number 127730 Approved/Revised 12-Jul-2004 Version 05
Material ALPHOSYL HC CREAM
ALLANTOIN
INGREDIENT
1
GSK Occupational
Hazard Category
HYDROCORTISONE
INGREDIENT
3
GSK Occupational
Hazard Category
SKIN
GSK Occupational 100 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
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.
Inhalation Toxicity Adverse effects might occur following inhalation.
* 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 Contains components that produced genotoxicity in laboratory tests.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. Coal tar is listed as a carcinogen by external agencies. (IARC);
(NTP).
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.
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SDS Number 127730 Approved/Revised 12-Jul-2004 Version 05
Material ALPHOSYL HC CREAM
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
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 Exempt when packaged for sale to consumers in a retail establishment.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 12-Jul-2004 SDS Version Number 5
SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Administrative
Containment
Exposure Controls
Eye Protection
Gloves
Occupational Hygiene Air Monitoring Methods
Occupational Hygiene Surface Monitoring Methods
Other Equipment or Procedures
Other Exposure Limits
Other Information
Other Protective Equipment
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SDS Number 127730 Approved/Revised 12-Jul-2004 Version 05
Material ALPHOSYL HC CREAM
SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Respirators
Surface Exposure Target
Ventilation
TOXICOLOGY INFORMATION Carcinogenicity
Eye Effects
Genetic Toxicity
Inhalation Toxicity
Oral Toxicity
Other Adverse Effects
Pharmacological Effects
Reproductive Effects
Sensitisation
Skin Toxicity
Target Organ Effects
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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