DETTOL ANTISEPTIC CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dettol Antiseptic Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

A 1 1    1        ,1                                                                      1­,1               ,           ‘,1 Z-X 1 /

Added as the approximate tri-potassium salt by reaction with 0.142% w/w potassium carbonate.

3 PHARMACEUTICAL FORM

Topical cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For application to the skin for use in cuts, bites, stings, abrasions, and for use as an antiseptic hand cream.

4.2 Posology and method of administration

For topical application to the skin.

Adults and children: Apply in small amounts directly on the skin as required. For cuts and grazes, clean the wound and surrounding skin by wiping gently with Dettol Cream, preferably on a piece of lint or cotton wool. For continued protection apply Dettol Antiseptic Cream again. If necessary, cover the injury with a clean dressing.

There is no indication that dosage need be modified for the elderly.

4.3 Contraindications

Allergic skin reactions, dermatitis, eczema or other skin complaints.

4.4 Special warnings and precautions for use

Treatment should be terminated if irritation develops. In the event of any irritation of sensitive skin, wash with lukewarm water.

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Fertility, Pregnancy and lactation

There is inadequate evidence of the safety of the drug in human pregnancy and lactation, but there has been wide use in humans without apparent ill consequence. Animal studies have shown no hazard. If drug therapy is needed in pregnancy this drug can be used if there is no safer alternative.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

4.9 Overdose

It is unlikely that a sufficient volume of the cream could be ingested to cause any medical problems. In the event of accidental eye contact, wash with luke warm water.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Chloroxylenol is an antiseptic agent whose activity is principally against Streptococci, but also has some activity against Staphylococci. Triclosan exhibits bacteriostatic activity against a wide range of Gram positive and Gram negative organisms. These active ingredients are themselves resistant to the Pseudomonas species, but inclusion of EDTA potentiates their activity against this organism.

5.2 Pharmacokinetic properties

Animal studies have shown that following dermal application chloroxylenol is rapidly absorbed (Cmax = 1–2 hours), extensively metabolised and excreted via the kidney with almost complete elimination within 24 hours. In man, similar application of triclosan resulted in only minimal percutaneous absorption (around 5%) following 24 hour occlusion to the skin. Subsequent metabolism occurs slowly (T^ = 10 hours), followed by rapid urinary excretion, principally as the glucuronide.

5.3 Preclinical safety data

No preclinical findings of relevance have been reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Emulsifying wax

Carbomer

Glycerol

Almond oil

Terpineol

Perfume ES9078

Potassium hydroxide solution 50%

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

Collapsible aluminium tube with an internal lacquer coating.

Pack size: 30g & 50g.

6.6 Special precautions for disposal

For topical application to the skin.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

103–105 Bath Road

Slough, SL1 3UH

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0764

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

04/11/2002 / 14/07/2003