Dermisol Cream
Revised: June 2014
AN: 00245/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dermisol Cream
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Malic acid anhydrous 0.375
% w/v
Benzoic acid 0.025 % w/v
Salicylic acid 0.006 % w/v
Propylene glycol 1.750 % v/v
For the full list of all other excipients see section 6.1
PHARMACEUTICAL FORM
Cream
A white cream for topical application.
CLINICAL PARTICULARS
Target species
Horses, cattle, dogs and cats.
Indications for use, specifying the target species
To encourage healing in horses, cattle, dogs and cats when this process is impaired by the presence of necrotic tissue, coagulum, debris or wax. This may occur in traumatic injury, surgical wounds, infected wounds and otitis externa.
Contraindications
Do not use this product in the treatment of otitis externa if the animal has a ruptured ear drum. If in doubt consult a veterinary surgeon.
Do not use in conjunction with other products e.g. teat dips, udder disinfectants, etc. as these will almost certainly neutralise and reduce the effectiveness of the product.
Special warnings for each target species
Contact with the eyes should be avoided as the solution may prove irritant on account of its low pH.
Special precautions for use
Special precautions for use in
animals
See section 4.7 (Use during pregnancy, lactation or lay).
For topical application only.
For external use
only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid contact with the eyes because of the low pH and a possibleirritant effect.
If contact occurs, rinse with clean, freshwater.
May cause skin irritation. It is recommended that gloves be worn when handling the product if you have sensitive skin.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
When used for treating udder lesions, the teats and udder should be washed and dried immediately before milking.
Interaction with other medicinal products and other forms of interaction
None.
Amounts to be administered and administration route
Apply twice daily although more frequent applications may be made
if necessary.
Wounds:The cream should be spread liberally on to wound surfaces and before each new application it is advisable to wash the area with a multicleansing solution so that loose slough and cream from the previous application are removed without raising the pH.
Otitis
externa:In cases of otitis externa, ears
should be cleaned with a multicleansing solution prior to the
introduction of the cream into the external auditory
canal.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal periods
Cattle: Meat – zero days.
Milk – zero hours
Horses: Meat – zero days.
PHARMACOLOGICAL PROPERTIES
The product has antibacterial properties because of its low pH - approximately 2.3 (due to the content of malic acid, benzoic acid and salicylic acid) and the presence of propylene glycol, which together with the sloughing action create an environment in which healthy tissues can readily grow. These components also ensure that the product is adequately preserved.
PHARMACEUTICAL PARTICULARS
List of excipients
White Soft Paraffin
Sorbitan Sesquioleate
Cholesterol
Magnesium Sulphate Heptahydrate
Allantoin
Methyl Hydroxybenzoate
Propyl Hydroxybenzoate
Water Purified
Incompatibilities
Prolonged contact with metal surfaces is inadvisable.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above
25°C.
Prolonged contact with metal surfaces is inadvisable.
Nature and composition of immediate packaging
Epoxyphenolic resin lacquered tube with white polyethylene cap (screwfit), containing either 30 g or 100 g. Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4035
DATE OF THE FIRST AUTHORISATION
Date:11 August 1992
DATE OF REVISION OF THE TEXT
Date:June 2014
26 June 2014