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DETTOL ANTISEPTIC CREAM

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Chloroxylenol
Triclosan
Edetic acid**

% w/w

Specification

0.30
0.30
0.20

BP
USP
EP

**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

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 (T½ = 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 (UK) Limited
103-105 Bath Road
Slough, SL1 3UH
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 19718/0001

9

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

10

DATE OF REVISION OF THE TEXT
22/11/2010

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Further information

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