Summary of medicine characteristics - DERMOL CREAM
1 NAME OF THE MEDICINAL PRODUCT
Dermol Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 QUALITATIVE AND QUANTITATIVE COMPOSITIONLiquid paraffin
Isopropyl myristate
Benzalkonium chloride
Chlorhexidine dihydrochloride
10.0% w/w
10.0% w/w
0.1% w/w
0.1% w/w
Excipients with known effect:
Cetostearyl alcohol
For the full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Cream
White non-greasy topical emulsion
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
An antimicrobial emollient cream for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The cream is suitable for direct application, and for use as a soap substitute.
4.2. Posology and method of administration
For external use only.
Before using the 500g pump bottle, turn the top of the pump dispenser anticlockwise to unlock it.
For adults, the elderly, infants and children.
For application to the skin
Apply Dermol Cream to the affected areas as often as necessary.
For use as a soap substitute
Dermol Cream may also be used as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.
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 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 Cream 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 Cream 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.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
No special precautions.
4.7. Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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.
Very rarely, hypersensitivity including anaphylactic reaction (see sections 4.3 and 4.4) is possible (based on literature for chlorhexidine-containing products).
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
Excessive topical use is very unlikely to cause any untoward effects other than making the skin feel greasy.
In the event of a significant quantity being accidentally swallowed, nausea and vomiting may occur but serious effects are unlikely. Unless there are signs that give cause for concern, treatment should be conservative.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
ATC Code: D02AX – Dermatologicals, other emollients and protectives.
Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema or dermatitis.
Dermol Cream contains 20% of emollient oils in a non-greasy aqueous cream 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 cream 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
5.3. Preclinical safety dataNo special information.
6.1
Cetostearyl alcohol
Glycerol
Macrogol cetostearyl ether (cetomacrogol)
Phenoxyethanol
Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Purified Water
6.2. Incompatibilities
None known
6.3
2 years.
6.4 Special precautions for storage
Do not store above 25°.
Replace cap after use.
6.5. Nature and contents of container
High density polyethylene squeezable bottle (500 g) with a polypropylene flip top cap.
High density polyethylene bottle (500 g) with a polypropylene metering pump.
High density polyethylene tube (100g) with a polypropylene screw cap.
Lacquered aluminium tube (30, 100g) with a polyethylene screw cap.
6.6. Instructions for use and handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin,
Hertfordshire, SG4 7QR
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00173/0171