DERMOL™ 500 LOTION

Benzalkonium Chloride 0.1% w/w; Chlorhexidine Dihydrochloride 0.1% w/w; Liquid Paraffin 2.5% w/w; Isopropyl Myristate 2.5% w/w.

Excipient : Cetostearyl Alcohol 5.0% w/w.

White, non-greasy cutaneous emulsion.

An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The lotion is suitable for direct application, and for use as a soap substitute.

For adults, children and the elderly: For application to the skin: apply the lotion to the affected areas as required. Massage into the skin, until absorbed. For use as a soap substitute: use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

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 lotion 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 or dermatitis. Dermol 500 Lotion contains 5% of emollient oils in a non-greasy aqueous lotion 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 lotion 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.

No special information.

Cetostearyl Alcohol; Macrogol Cetostearyl Ether (cetomacrogol); Phenoxyethanol; Purified Water.

None known.

30 months.

Do not store above 25°C. Replace cap after use.

Plastic 500 ml bottle with a white pump dispenser. Supplied as an original pack (OP).

No special requirements.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, HertsSG4 7QR, UK.

00173/0051.

23 June 2009.

November 2010.