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DETTOL ANTISEPTIC CREAM

Active substance(s): CHLOROXYLENOL / EDETIC ACID / TRICLOSAN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Cream

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Chloroxylenol Triclosan Edetic acid** % w/w 0.30 0.30 0.20 Specification BP USP EP

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

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PHARMACEUTICAL FORM
Topical cream

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4.1

CLINICAL PARTICULARS
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

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.

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5.1

PHARMACOLOGICAL PROPERTIES
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.

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6.1

PHARMACEUTICAL PARTICULARS
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 (UK) Limited 103-105 Bath Road Slough, SL1 3UH United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 19718/0001

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/11/2002 / 14/07/2003

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DATE OF REVISION OF THE TEXT
22/11/2010

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Source: Medicines and Healthcare Products Regulatory Agency

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