DERMOL^® WASH CUTANEOUS EMULSION

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 List of excipients.

White, non-greasy cutaneous emulsion.

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 (e.g. after washing)

Apply to the affected areas as required.

Do not use in cases of known sensitivity to any of the ingredients.

Avoid contact with the eyes.

The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people.

None known.

No special precautions.

None known.

Although the cream has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.

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.

Not applicable.

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.

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.

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.

Cetostearyl Alcohol; Cetomacrogol 1000; Phenoxyethanol; Purified Water.

None known.

30 months.

Do not store above 25°C.

200 ml plastic bottle with pump dispenser.

No special requirements.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/0407.

30 April 2010.

December 2010.