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SDS Number 134006
Approved/Revised 27-Jul-2011
Version 2
Material
SAFETY DATA SHEET
* 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Material
Synonym(s)
VELTIN (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL, 1.2% / 0.025% * CLINDAMYCIN- TRETINOIN GEL (CLINDAMYCIN 1% - TRETINOIN 0.025%) * FORMULATION CODE:R0843-r3 * STIEFEL PRODUCT * CLINDAMYCIN PHOSPHATE AND TRETINOIN,FORMULATED PRODUCT Recommended Use
This safety data sheet is written to provide health, safety and environmental information for peoplehandling this formulated product in the workplace. It is not intended to provide information relevantto medicinal use of the product. In this instance patients should consult prescribinginformation/package insert/product label or consult their pharmacist or physician. For health andsafety information for individual ingredients used during manufacturing, refer to the appropriatesafety data sheet for each ingredient.
Company Name
Stiefel Laboratories, Inc. (a GSK company)GlaxoSmithKline UK980 Great West RoadBrentford, Middlesex TW8 9GS UKUK General Information (normal business hours): +44-20-8047-5000 GlaxoSmithKline US5 Moore DriveResearch Triangle Park, NC 27709 USAUS General Information (normal business hours): +1-888-825-5249 Email Address: [email protected]: www.gsk.com TRANSPORT EMERGENCIES (by country / geographic region):Africa / EU / Israel / Middle East (English / European languages): +44 (0) 1235 239 670Asia Pacific (except China): +65 3158 1074China: +86 10 5100 3039Middle East / Africa (Arabic-speaking countries): +44 (0) 1235 239 671US: +1 703 527 3887available 24 hrs/7 days; multi-language response MEDICAL EMERGENCIES: +1 612 221 3999, Ext 221available 24 hrs/7 days; multi-language response Caution - Pharmaceutical agent.
Caution - The toxicological properties of this material have not been fully investigated.
Not expected to be a health hazard during normal handling.
Health effects information is based on hazards of components.
Contains one or more components, categorised as potentially harmful to the development ofunborn offspring.
Overexposure might lead to increased sensitivity of the skin to ultraviolet radiation and sunlight.
Exposure might occur via ingestion; skin; eyes.
SDS Number 134006
Approved/Revised 27-Jul-2011
Version 2
Material
Environment
No information is available about the potential of this product to produce adverse environmentaleffects.
3. COMPOSITION / INFORMATION ON INGREDIENTS Ingredients
Ingestion
Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if theexposed subject is unconscious or semi-conscious. Wash out the mouth with water. If theexposed 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 flushexposed area with large amounts of water. Obtain medical attention if skin reaction occurs, whichmay be immediate or delayed.
Eye contact
Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtainmedical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment
Treat according to locally accepted protocols. For additional guidance, refer to the currentprescribing information or to the local poison control information centre.
Medical Conditions
Refer to prescribing information for detailed description of medical conditions caused by or Caused or Aggravated by
aggravated by overexposure to this product.
Exposure
Health Surveillance
Pre-placement and periodic health surveillance is not usually indicated. The final determination of Procedures
the need for health surveillance should be determined by local risk assessment.
Antidotes
No specific antidotes are recommended.
Fire and Explosion Hazards
Not expected for the product, although the packaging is combustible.
Extinguishing Media
Special Firefighting
For single units (packages): No special requirements needed.
Procedures
For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or flammablevapours might be evolved from fires involving this product and associated packaging, selfcontained 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 Products
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 drainagesystems.
Clean-up Methods
Collect and place it in a suitable, properly labelled container for recovery or disposal.
Decontamination Procedures
No specific decontamination or detoxification procedures have been identified for this product.
SDS Number 134006
Approved/Revised 27-Jul-2011
Version 2
Material
HANDLING
GSK Process Hazard
Category
General Requirements
No special control measures required for the normal handling of this product. Normal roomventilation is expected to be adequate for routine handling of this product.
No storage requirements are considered necessary for the control of fire and explosion hazards.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION OCCUPATIONAL EXPOSURE LIMITS
INGREDIENT
GSK Occupational Hazard
Category
GSK Occupational Exposure 4 mcg/m3 (8 HR TWA)
Other Equipment or
None required for normal handling. Wash hands and arms thoroughly after handling.
Procedures
Appearance
Physical Form
Stability
This product is expected to be stable.
Conditions to Avoid
None for normal handling of this product.
Pharmacological Effects
This product contains active ingredient(s) with the following activity: a retinoid (vitamin Aderivative); an antibiotic.
Target Organ Effects
No specific target organ effects have been identified.
Routes of Exposure
Oral Toxicity
Not expected to be toxic following ingestion.
Assessment based upon effects of individual components.
Inhalation Toxicity
Skin Effects
Irritation is not expected following direct contact.
Assessment based upon effects of individual components.
Eye Effects
Irritation is not expected following direct contact with eyes.
Assessment based upon effects of individual components.
Sensitisation
Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity
Not expected to be genotoxic, based on effects of individual components.
Carcinogenicity
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 exposureconditions.
Contains components which have been classified as: Possible risk of toxicity in developinghuman offspring.
Other Adverse Effects
Overexposure might lead to increased sensitivity of the skin to ultraviolet radiation and sunlight.
SDS Number 134006
Approved/Revised 27-Jul-2011
Version 2
Material
This material contains an active ingredient that has been tested and which may be harmful ifreleased directly to the environment. Consult the MSDS of the active ingredient for specificinformation about potential environmental effects. Local regulations and procedures should beconsulted prior to environmental release.
Disposal Recommendations
Collect for recycling or recovery if possible. The disposal method for rejected products/returnedgoods must ensure that they cannot be re-sold or re-used.
Regulatory Requirements
Observe all local and national regulations when disposing of this product.
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trainedand competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods fortransport.
UN Classification and Labelling
Transport Information
The information included below is an overview of the major regulatory requirements. It should not be considered to be an exhaustivesummary. 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
References
SDS Version Number
SDS Sections Updated
Sections
Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OFCOMPANY 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 theapplicability of this information and the suitability of the material or product for any particular purpose.

Source: http://www.msds-stiefel.com/assets/PDF/134006.pdf