Dettol Antiseptic Cream

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

Topical cream

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

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.

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

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

None known.

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.

None known.

None known.

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.

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.

Animal studies have shown that following dermal application chloroxylenol is rapidly absorbed (C_max = 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 (T½ = 10 hours), followed by rapid urinary excretion, principally as the glucuronide.

No preclinical findings of relevance have been reported.

Emulsifying wax

Carbomer

Glycerol

Almond oil

Terpineol

Perfume ES9078

Potassium hydroxide solution 50%

Purified water

None known.

Three years.

None.

Collapsible aluminium tube with an internal lacquer coating.

Pack size: 30g & 50g.

For topical application to the skin.

Reckitt Benckiser (UK) Limited

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

PL 19718/0001

04/11/2002 / 14/07/2003

22/11/2010