a) A mild antiseptic for topical administration on dilution with water or, in emergencies, undiluted.

b) For relief of sore throats, bad breath, mouth ulcers, painful gums and for topical administration in the treatment of minor wounds of the skin including cuts, grazes, stings and scalds.

Adults, children and the elderly.

Relief of sore throat symptoms including those associated with colds and flu Night and morning gargle with TCP diluted with 5 parts water.

DO NOT SWALLOW THIS SOLUTION.

Mouthwash

For bad breath – rinse daily after meals, diluted with 5 parts of water. For mouth ulcers – dab undiluted on the affected area three times daily. If symptoms persist for more than 14 days consult your dentist.

Cuts, grazes, bites and stings

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

Spots, pimples and blisters

Dab lightly every 4 hours and allow to dry.

Hypersensitivity to any of the active constituents.

If symptoms persist for more than 14 days a doctor should be consulted. Use in allergic skin conditions should be avoided.

Avoid contact with eyes.

Sickness can occur after accidental oral intake.

None known.

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

None known.

The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

The risk of undesirable effect is low with appropriate use.

Body System Class	Undesirable Effect	Frequency
Nervous system disorders	Mouth paresthesia, dysgeusia	Not known
Skin and subcutaneous tissue disorders	Blisters, buccal ulcer, swelling, burns, redness, pruritus, dry skin, skin necrosis, skin peeling, pain	Not known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/; e-mail: medsafety@hpra.ie

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.

Halogenated phenols act on all pathogenic micro-organisms similarly and to approximately the same degree - i.e. they are non-specific; and 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.

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

None stated.

Glycerol

Concentrated phosphoric acid Quinoline yellow (E104) Purified water

Not applicable.

3 years.

Do not store above 30°C.

TCP Liquid Antiseptic is stored in amber soda-lime glass bottles of 50 ml, 100 ml and 200 ml capacity which are uncoated. The cap is either a white cap of wood-filled urea formaldehyde with an expanded polyethylene wad or a white 'wadless' polypropylene cap.

No special requirements.