Dermol Wash Cutaneous Emulsion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermol Wash Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin 2.5% w/w
Isopropyl Myristate 2.5% w/w
Benzalkonium Chloride 0.1% w/w
Chlorhexidine Dihydrochloride 0.1% w/w
Excipient:
Cetostearyl Alcohol 5.0% w/w
For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous emulsion
White, non-greasy cutaneous emulsion.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol Wash Cutaneous Emulsion is suitable for direct application and for use as a soap substitute.
For adults, children and the elderly. For cutaneous use only.
For use as a soap substitute
Use as a cleanser at the sink or to wash with in the bath or shower, instead of ordinary soap or shower gel. Pat the skin dry using a soft towel (avoid rubbing as this can irritate the skin).
The product may also be used in a similar way for frequent hand washing.
For application to the skin (eg after washing)
Apply to the affected areas as required.
4.3 Contraindications
Do not use in cases of known sensitivity (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8).
4.4 Special warnings and precautions for use
Avoid contact with the eyes.
Local skin reactions (e.g. contact dermatitis) to any of the ingredients, in particular cetostearyl alcohol, are rare but possible in sensitive people.
There are literature reports of chlorhexidine compounds inducing hypersensitivity, including anaphylactic shock. The prevalence of this is not known, but is likely to be very rare. Dermol Wash Cutaneous Emulsion should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
None known.
No special precautions.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Although the product has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction, discontinue treatment.
Local skin reactions
These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.
Serious generalised allergic reactions
Very rarely, hypersensitivity including anaphylactic reaction (see sections 4.3 and 4.4) is possible (based on literature for chlorhexidine-containing products).
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
ATC code: D02 AX, emollients and protectives.
Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema and dermatitis.
Dermol Wash contains 5% of emollient oils in a non-greasy aqueous system which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from Staph aureus, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching.
Massaged into the skin, the emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.
5.2 Pharmacokinetic properties
The active ingredients are presented in an aqueous emulsion system and so are readily absorbed into the stratum corneum when the product is gently massaged over the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol cetostearyl ether (cetomacrogol 1000) Cetostearyl alcohol
Phenoxyethanol Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
30 months in unopened container
In-use - 18 months (container sizes greater than 250 ml)
6.4 Special precautions for storage
Do not store above 25°C. Replace cap after use.
6.5 Nature and contents of container
High density polyethylene bottle (50, 200 or 500 ml) with either a white polypropylene metering pump or a white polypropylene dispensing stopper/screw cap.
6.6 Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
7
Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire, SG4 7QR UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00173/0407
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/04/2010
10 DATE OF REVISION OF THE TEXT
16/10/2014