OCCLUSAL Cutaneous solution (2015)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Occlusal. 26% w/w cutaneous solution.
Qualitative and quantitative composition
Salicylic Acid 26% w/w. For excipients, see 6.1
Pharmaceutical form
Cutaneous solution. A colourless to pale yellow solution with a characteristic smell of nail varnish.
Therapeutic indications
Occlusal is indicated for the treatment and removal of common and plantar warts (verrucae).
Posology and method of administration
For topical application. Prior to application soak wart in warm water for five minutes. Remove loose tissue with a brush, emery board, pumice or abrasive sponge, being careful to avoid causing pin-point ...
Contraindications
Hypersensitivity to salicylic acid or to any of the excipients. Occlusal should not be used by diabetics or patients with impaired blood circulation. Do not use if the wart or surrounding skin is inflamed ...
Special warnings and precautions for use
Occlusal is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using ...
Interaction with other medicinal products and other forms of interaction
There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Occlusal and other topical medicines ...
Pregnancy and lactation
Whilst there are no known contra-indications to use of Occlusal during pregnancy and lactation, the safety has not been established. Occlusal should therefore be used with caution or following professional ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 ...
Overdose
Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Wart and anticorn preparations ATC code: D11AF Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal ...
Pharmacokinetic properties
Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Occlusal.
Preclinical safety data
No other information relevant to the prescriber other than that already stated in other sections of the SPC.
List of excipients
Polyvinyl butyral Dibutyl phthalate Isopropyl alcohol Butyl acetate Acrylates copolymer
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
The product is presented in a 10ml amber glass bottle with cap brush assembly. The cap brush assembly comprises of a black cap and a white polythene wand nylon brush with stainless steel staple.
Special precautions for disposal and other handling
Occlusal is flammable and should be kept away from flame or fire. Keep the bottle tightly capped when not in use. Do not allow the solution to drip from the brush onto the bottle neck thread, otherwise ...
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, 2 Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
Marketing authorization number(s)
PL 16853/0071
Date of first authorization / renewal of the authorization
7<sup>th</sup> September 1998/18<sup>th</sup> May 2005
Date of revision of the text
20<sup>th</sup> March 2015
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