Dermol 500 Lotion

1. Name Of The Medicinal Product

DERMOL™ 500 LOTION

2. Qualitative And Quantitative Composition

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.

3. Pharmaceutical Form

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. The lotion is suitable for direct application, and for use as a soap substitute.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

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 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.

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 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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetostearyl Alcohol; Cetomacrogol 1000; Phenoxyethanol; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0051.

9. Date Of First Authorisation/Renewal Of The Authorisation

23 June 2009.

10. Date Of Revision Of The Text

March 2010.