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Drug information

TCP

OTC
Read time: 2 mins
Last updated: 29 Sep 2014

Summary of product characteristics


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.


4.1. 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. Fertility, 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.


5.1. 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.


6.1. 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

Omega Pharma Ltd.1st Floor32 Vauxhall Bridge Road LONDON, SW1V 2SAUnited 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

20th December 2012

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 Fertility, 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.

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Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

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Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).