Doublebase Emollient Wash Gel

1. Name Of The Medicinal Product

DOUBLEBASE™ EMOLLIENT WASH GEL

2. Qualitative And Quantitative Composition

Isopropyl Myristate 15% w/w; Liquid Paraffin 15% w/w.

3. Pharmaceutical Form

White opaque gel.

4. Clinical Particulars

4.1 Therapeutic Indications

A highly emollient and protective hydrating base for regular first-line treatment and prophylaxis of dry or chapped skin conditions which may also be pruritic (itchy) or inflamed. The product may also be used as an adjunct to other topical treatments.

4.2 Posology And Method Of Administration

For adults, the elderly and children. For cutaneous use only. Use regularly and as often as necessary.

• Use the product to gently wash the skin.

• Rinse off and pat the skin dry using a soft towel. (Avoid rubbing as this can irritate the skin).

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

Take care not to slip if using the product in the bath or shower. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent.

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

No special precautions.

4.8 Undesirable Effects

Although the product has been specially formulated for use on dry, problem or sensitive skin, local skin reactions can occur in rare cases. In this event, treatment should be discontinued.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: D02A, emollients and protectives.

The oily ingredients, isopropyl myristate and liquid paraffin, encourage rehydration and softening 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 product is also suitable for use as a soap substitute owing to the presence of a non-ionic emulsifier (cetomacrogol).

5.2 Pharmacokinetic Properties

Because the product is designed to deliver the emollient ingredients into the stratum corneum when gently applied to areas of dry skin, it is relatively non-greasy despite its high oil content.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol; Carbomer; Sorbitan Laurate; Triethanolamine; Phenoxyethanol; Cetomacrogol 1000; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not freeze.

6.5 Nature And Contents Of Container

200g plastic bottle with pump dispenser.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0402.

9. Date Of First Authorisation/Renewal Of The Authorisation

8 September 2008.

10. Date Of Revision Of The Text

March 2009.