Dermol 500 Lotion
Excipients with known effect:
For the full list of excipients, see Section 6.1
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 (especially generalised allergic reaction) to any of the ingredients (see sections 4.4 and 4.8).
Avoid contact with the eyes.
Take care to avoid slipping in the shower or bath, when using as a soap substitute.
Local skin reactions (e.g. contact dermatitis) to any of the ingredients 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 500 Lotion should not be administered to anyone with a possible history of allergic reaction to a chlorhexidine compound (see sections 4.3 and 4.8).
Dermol 500 Lotion contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Use during pregnancy and lactation is not expected to be associated with harmful effects to the mother as cutaneous absorption of benzalkonium chloride is minimal. When breast-feeding, if use on the nipples is necessary, apply sparingly and after feeds. Gently wipe away any remaining product before feeding your baby.
Although the lotion 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. or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
Macrogol cetostearyl ether (cetomacrogol)
30 months in unopened container (all pack sizes apart from the 50 ml bottle)
24 months in 50 ml bottle container
In-use - 18 months (container sizes greater than 250 ml)
Do not store above 25°C.
Replace cap after use.
High density polyethylene BOTTLE (50, 75, 100, 125, 150, 200, 250, 300, 350 or 500 ml) with either a white polypropylene METERING PUMP or a white polypropylene dispensing STOPPER/CAP as appropriate.
Paper/polyethylene/foil/polyethylene laminate SACHET (5 or 10 ml) packaged into unit cartons in appropriate multiples to match the above bottle capacities.
Supplied as original packs (OP).
No special requirements.
Diomed Developments Limited
T/A Dermal Laboratories
Hertfordshire SG4 7QR
16 January 1991 / 23 June 2009 (for 01/10/07 renewal date, PSUR-Renewal unlimited validity granted)