DETTOL LIQUID, DETTOL ANTISEPTIC DISINFECTANT 4.8% W/V CONCENTRATE FOR CUTANEOUS SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dettol Liquid

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Concentrate for cutaneous solution.

Clear amber liquid with pine oil odour, free from particulate matter.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Medical – for cuts, bites, abrasions and insect stings.

Personal hygiene – for douching, dandruff; and spots and pimples.

4.2 Posology and Method of AdministrationPosology(a) Medical uses

For cuts, bites, abrasions and insect stings: wash the area with one tablespoonful of Dettol diluted in a half pint of water and cover with dry gauze or lint.

For douching (when medically advised): two teaspoonfuls of Dettol diluted in two pints of warm water.

For dandruff: one tablespoonful of Dettol diluted in one pint of warm water. Saturate hair and scalp for 10 minutes, then shampoo.

For spots and pimples: bathe the affected area daily with one tablespoonful of Dettol diluted in half a pint of warm water (not for eczematous conditions).

For external use only.

Always dilute the product before use.

4.3 Contraindications

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

Do not use on eczematous conditions

4.4 Special warnings and precautions for use

For external use only.

Not for use around eyes, ear, 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.

This medicine contains trace amounts of benzyl alcohol.

Benzyl alcohol may cause allergic reactions and mild local irritation.

This medicine contains fragrance with d-limonene.

d-Limonene may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction Not applicable.

4.6 Fertility, pregnancy and lactationPregnancy

No effects during pregnancy are anticipated, since systemic exposure from topical chloroxylenol use is negligible. Chloroxylenol can be used during pregnancy.

Breast-feeding

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

No data on human fertility are available

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Adverse events which have been associated with chloroxylenol are given below, tabulated by system organ class and frequency. Frequencies are defines 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.

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

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Symptoms

Topical application of undiluted chloroxylenol can cause skin burning. Symptoms reported include corrosion of the oral mucosa, larynx, and the gastrointestinal tract, bradycardia, hypotension, and renal failure. Large amounts may cause CNS depression. Pulmonary aspiration of chloroxylenol-based disinfectants may result in pneumonia, acute respiratory distress syndrome, and cardiorespiratory arrest. There have been reports of death by excessive consumption.

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

In the case of ingestion or excess exposure, seek medical advice immediately. Careful observation of airway patency for 24–48 hours should be made postingestion.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic propertiesPharmacotherapeutic group:

Dermatologicals; Antiseptics and disinfectants; Phenol and derivatives; Chloroxylenol; ATC Code: D08AE05.

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

No preclinical findings of relevance have been reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pine oil (contains d-limonene and benzyl alcohol)

Isopropyl alcohol

Castor oil

Caustic soda solution

Caramel

Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

There are no special precautions for storage.

6.5 Nature and contents of container

Polypropylene and Polyvinylchloride bottles with polypropylene screw cap with HDPE faced wadding.

Pack sizes: 125, 250, 500, 750, 1000ml.

Plastic Bottles:

Pack Sizes: 2L, 4L and 5L.

Not all packs will be marketed.

6.6 Special precautions for disposal

For external use only.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

103–105 Bath Road

Slough

SL1 3UH

United Kingdom