HEALTH AND SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY COMPANY ADDRESS: Dechra Pharmaceuticals PLC 24 Cheshire Avenue Cheshire Business Park Lostock Gralam Northwich CW9 7UA UK Tel: +44 (0) 1606 814730 Fax: +44 (0) 1606 814731 PRODUCT NAMES: ISADERM GEL FOR DOGS [Previously known as Fuciderm] ISSUE DATE: 01 June 2015 PHYSICAL FORM: Colourless Gel PRODUCT TYPE: Topical treatment of surface pyoderma in dogs CONTAINER: Aluminium tubes 2. HAZARDS IDENTIFICATION: The product shall not be classified as hazardous according to the national classification and labelling rules. Additional information Long-term excessive use can cause side effects from the active substance Betamethasone valerate. 3. COMPOSITION/INFORMATION ON ACTIVE INGREDIENTS Einecs no Substances Classification w/w% 218-439-3 Betamethasone valerate T; R23 Xn; R21/22 R63 <1 Please see section 16 for the full text of the R-phrases Version: 01 June 2015 Page 1 of 5
4. FIRST-AID MEASURES EYE CONTACT: DERMAL CONTACT: INGESTION: INHALATION: OTHER INFORMATION: Flush immediately with water (preferably using eye wash equipment) for at least 5 minutes. Open eye wide. Remove any contact lenses. Seek medical advice if symptoms persist. Remove contaminated clothing. Wash skin with soap and water. Wash out mouth thoroughly and drink 1-2 glasses of water in small sips. Seek medical advice in case of persistent discomfort. Seek fresh air When obtaining medical advice, show the safety data sheet or label. 5. FIRE-FIGHTING MEASURES Extinguish with powder, foam, carbon dioxide or water mist. Do not use water stream, as it may spread the fire. Use water or mist to cool non-ignited stock. Move containers from danger area if it can be done without risk. Avoid inhalation of vapour and flue gases seek fresh air 6. ACCIDENTAL RELEASE MEASURES Use the same personal protective equipment as stated in section 8. See section 13 for instructions on disposal. Wipe up minor spills with a cloth. Rinse with water. 7. HANDLING AND STORAGE HANDLING: STORAGE: See section 8 for information about precautions for use and personal protective equipment. Avoid contact with skin and eyes. Store safely and keep out of the reach of children. Store at room temperature. Version: 01 June 2015 Page 2 of 5
8. EXPOSURE CONTROLS/PERSONAL PROTECTION: Precautions for use Running water and eye wash equipment must be available. Wash hands before breaks, before using restroom facilities, and at the end of work. Respiratory protection Not required. Gloves and protective clothing Wear protective gloves made of nitrile rubber or polyethylene. Eye Protection Wear safety goggles if there is a risk of eye splash. Occupational exposure limits Contains no substances subject to reporting requirements 9. PHYSICAL AND CHEMICAL PROPERTIES OF ACTIVE STATE: Gel ODOUR: Odourless COLOUR: Colourless 10. STABILITY AND REACTIVITY: The product is stable when used with the supplier s directions. 11. TOXICOLOGICAL INFORMATION EYE CONTACT: DERMAL CONTACT: INGESTION: INHALATION: May cause eye irritation. May cause slight irritation. Ingestion may cause discomfort. The product does not release hazardous vapours. Version: 01 June 2015 Page 3 of 5
12. ECOLOGICAL INFORMATION: Avoid discharge to drain or surface water. 13. DISPOSAL CONSIDERATIONS: Contact the local authorities. EWC code: Depends on line of business and use, for instance 18 01 09 medicines other than those mentioned in 18 01 08 Absorbent/cloth contaminated with the product: EWC code: 15 02 03 absorbents, filter materials, wiping cloths and protective clothing other than those mentioned in 15 02 02 14. TRANSPORT INFORMATION: The product is not covered by the rules for transport of dangerous goods by road and sea according to ADR and IMDG. 15. REGULATORY INFORMATION Hazard designation Other labelling Chemical safety assessment It has been assessed that the product need not be classified according to the national classification and labelling rules. None. Chemical safety assessment has not been performed. Version: 01 June 2015 Page 4 of 5
16. OTHER INFORMATION Restrictions on use None Training requirement No special training is required, but a thorough knowledge of this safety data sheet should be a prerequisite condition. Sources Used ADR 2007 edition and IMDG 2006 edition. SI 2002/1689 The chemicals (Hazard information and Packaging for Supply) Regulations 2002, last amended by regulation 1907/2006/EC. Approved Supply List (seventh edition): Information approved for the classification and labelling of substances and preparations dangerous for supply. Chemicals (Hazard Information and Packaging for Supply) Regulations 2002, 29. ATP. EH40/2005 Workplace exposure limits incl. Supplement from October 2007. SI 2005/895 The list of Wastes (England) Regulations 2005 Other information This safety data sheet was prepared from information provided by the supplier about physical/chemical properties and all ingredients in the product. Full text of the R-phrases that are stated in section 3. R21/22 Harmful in contact with skin and if swallowed. R23 Toxic by inhalation R63 Possible risk of harm to the unborn child. Prepared by Dechra Pharmaceuticals PLC on the basis of the best available data. No representation is given that the information provided is complete in all respects. Version: 01 June 2015 Page 5 of 5