Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution

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

Posology:

Adults:

Wash the affected area with product at 5% dilution (50 ml product in 1 litre of water)

Paediatric population:

Children over the age of 1 year: As above for adults

Children under the age of 1 year: Not for use in children under 1 year of age.

Method of administration:

Apply topically to relevant area as required.

Do not use undiluted.

Hypersensitivity to chloroxylenol or any of the excipients listed in section 6.1.

Do not use on eczematous conditions.

Not for use on children under 1 year of age.

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

For external use only. Do not use undiluted.

Not for use around eyes, ears, nose or mouth. If contact is made, wash thoroughly with cold water.

Not for use on large areas of the body or on sensitive skin.

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 sight and reach of children.

Not applicable.

Pregnancy:

No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. As with all medicines, this product should be used with caution during pregnancy.

Breast-feeding:

It is unknown whether chloroxylenol or its metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast-feeding.

Fertility:

No data on human fertility are available.

Not applicable.

Adverse events which have been associated with chloroxylenol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very Common ((≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Contains castor oil, may cause skin reactions.

System Organ Class	Frequency	Adverse Events
Immune System Disorders	Not known	Hypersensitivity
Skin and Subcutaneous Tissue Disorders	Not known	Skin sensitization, dermatitis contact1, skin discolouration, rash
Administration Site Conditions	Not known	Application site irritation, application site burn

Description of Selected Adverse Reactions

¹ Contact dermatitis can be associated with pruritus, erythema, skin scaling, itching and stinging

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: www.hpra.ie; E-mail:medsafety@hpra.ie

Symptoms:

Topical application of undiluted chloroxylenol can cause skin burning.

Oral ingestion may result in pharyngeal erosion, laryngeal oedema, stomatitis, bradycardia, hypotension, renal failure and CNS depression. Pulmonary aspiration following ingestion may result in pheumonia, acute respiratory distress syndrome and cardiorespiratory arrest. There have been reports of deaths by excessive consumption.

Management:

In the case of accidental ingestion or excess exposure, wash out mouth and drink plenty of water or milk and contact your doctor immediately. Careful observation of airway patency for 24-48 hours should be made post-ingestion.

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.

Pack sizes: 125 ml, 250 ml, 275 ml, 500 ml, 550 ml, 750 ml

4L HDPE bottles with polypropylene screw cap.

Not all pack sizes may be marketed.

For external use only.