Reckitt Benckiser Ireland Limited

Dettol Liquid Antiseptic Disinfectant 4.8% w/v concentrate for cutaneous solution

Active substance

Chloroxylenol 4.8% w/v

Excipients: Castor Oil Soap 14.0 – 15.2% v/v

For a full list of excipients, see section 6.1

Concentrate for cutaneous solution.

An amber coloured liquid with an odour of pine oil.

As an antiseptic for prophylaxis of topical infection in intact and abraded skin and for skin preparation prior to surgical or diagnostic procedures.

Apply topically to relevant areas as required. Do not use undiluted.

Use in persons hypersensitive to the active ingredient or any of the excipients.

If the condition persists or is aggravated, discontinue use and consult the doctor.

For external use only. Do not use undiluted.

If swallowed, wash out mouth and drink plenty of water or milk. If contact is made with eyes, wash thoroughly with cold water. In both cases consult your doctor.

Keep out of the reach and sight of children.

Not applicable.

Not applicable.

Not applicable.

Contains castor Oil, may cause skin reactions.

May cause skin discolouration, application site irritation, burns, rash, pruritus, erythema or contact dermatitis.

Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia and CNS depression.

In the case of accidental ingestion wash out mouth and drink plenty of water or milk and contact your doctor.

ATC Code: D08AE05, Phenol and derivatives

Chloroxylenol is a substituted phenol which has been widely used for many years as an ingredient of antiseptic/disinfectant products intended for external use. It is known to be bactericidal in low concentration to a wide range of Gram positive and Gram negative bacteria.

Chloroxylenol is well-absorbed when applied to the skin. It is extensively metabolised in the body, probably by the liver, and rapidly excreted, mainly in the urine, as sulphate and glucuronide conjugates. Chloroxylenol has a low systemic toxicity, even at dosage levels many times higher than those likely to be absorbed during normal usage of Dettol Liquid.

No preclinical findings of relevance have been reported.

Pine oil,

Isopropyl alcohol,

Castor oil soap

Caramel

Water.

Not applicable.

Three years.

No special precautions requirements.

Polypropylene and polyvinylchloride bottles with polypropylene screw cap with PVdC wad.

Glass bottles with hard plastic screw cap.

Pack sizes: 125 ml, 250 ml, 275 ml, 500 ml, 550 ml, 750 ml, 4 l.

Not all pack sizes may be marketed.

For external use only.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/4/2.

Date of first authorisation: 1st April, 1993

Date of last renewal: 1st April 2003

August 2009.