Dettol Antiseptic Disinfectant 4.8% W/V Concentrate For Cutaneous Solution
SUMMARY OF PRODUCT 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
Active ingredient % w/v Specification
Chloroxylenol 4.8 BP
3 PHARMACEUTICAL FORM
Concentrate for cutaneous solution.
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 administration
For external use only.
(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 urgent application, Dettol may be used undiluted, but not on sensitive skins.
(b) Personal hygiene
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).
4.3 Contraindications
Not applicable.
4.4 Special warnings and precautions for use
For external use only.
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 of children.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Fertility, pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Not applicable.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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
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 PVdC faced wadding.
Pack sizes: 125, 250, 500, 750, 1000ml.
Plastic Bottles.
Pack Sizes: 2L, 4L and 5L.
6.6 Special precautions for disposal
For external use only.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser (UK) Limited
103-105 Bath Road
Slough
SL13UH United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 19718/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/11/1986
10 DATE OF REVISION OF THE TEXT
02/02/2015