Friday, 23 March 2012

TCP Antiseptic Liquid





1. Name Of The Medicinal Product



TCP Liquid Antiseptic


2. Qualitative And Quantitative Composition



Active ingredients: TCP Liquid Antiseptic is an aqueous solution of Phenol 0.175% w/v and halogenated phenols 0.68% w/v.



3. Pharmaceutical Form



Aqueous liquid antiseptic.



4. Clinical Particulars



4.1 Therapeutic Indications



Symptomatic relief of sore throats including those associated with colds and influenza. Common mouth ulcers, cuts, grazes, bites, stings, boils, spots and pimples.



4.2 Posology And Method Of Administration



Adults, children and the elderly.



Symptomatic relief of sore throats including those associated with colds and flu.



Gargle twice a day with TCP diluted with 5 parts water. Do not swallow.



Common mouth ulcers.



Dab undiluted onto affected areas three times a day. If symptoms persist for more than 14 days, consult your doctor or dentist.



Cuts, grazes, bites and stings.



Dilute with an equal quantity of water and apply freely. In emergencies may be used undiluted.



Boils, spots and pimples.



Dab undiluted every 4 hours. Do not cover.



4.3 Contraindications



Hypersensitivity to any of the active ingredients



4.4 Special Warnings And Precautions For Use



Seek medical advice if symptoms persist for more than a few days.



Keep out of the reach and sight of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is no experience of the use of the product in pregnancy and lactation, but the product has been widely used for many years with no adverse effects.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Use in allergic skin conditions should be avoided.



4.9 Overdose



Serious adverse events are unlikely to result from overdosage of this product.



Accidental ingestion: If a quantity (over 30ml) of neat TCP is swallowed accidentally, drink 0.5 to 1 litre of water immediately. If discomfort persists, seek medical advice.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Halogenated phenols act on all pathogenic micro-organisms similarly and to approximately the same degree - i.e. they are non-specific, their activity is not appreciably reduced by the presence of relatively large amounts of non-living organic matter, their relatively simple chemical constitution means that their use is not liable to encourage the emergence of strains of micro-organisms adapted to resist their action.



5.2 Pharmacokinetic Properties



TCP Liquid Antiseptic is for topical use only. Significant absorption from this topical dosage form is considered unlikely.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Other ingredients: glycerol, concentrated phosphoric acid, quinoline yellow (E104) and purified water.



6.2 Incompatibilities



None known.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



None.



6.5 Nature And Contents Of Container



TCP Liquid Antiseptic is stored in amber flint glass bottles of 50ml, 100ml and 200ml capacity, with white wadless polypropylene tamper-evident caps, or 500ml amber flint glass bottles with white wadless polypropylene caps.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



Chefaro UK Ltd,



4th Floor, Hamilton House,



Mabledon Place, Bloomsbury,



LONDON, WC1H 9BB



United Kingdom



8. Marketing Authorisation Number(S)



PL 02855/0021



9. Date Of First Authorisation/Renewal Of The Authorisation



16th November 2004



10. Date Of Revision Of The Text



14th November 2010



LEGAL CATEGORY


GSL




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