Doublebase Gel

1. Name Of The Medicinal Product

DOUBLEBASE™ GEL

2. Qualitative And Quantitative Composition

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

For excipients see List of Excipients.

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. Doublebase may also be used as an adjunct to other topical treatments.

4.2 Posology And Method Of Administration

For external use only. Before using the 500 g bottle, turn the top of the pump dispenser anti-clockwise to unlock it.

For adults, the elderly, infants and children:

• Apply Doublebase to the affected areas as often as necessary. For best results use a few gentle strokes to smooth Doublebase across the skin in the same direction as hair growth. If necessary, allow time for any excess to soak in. Do not rub vigorously.

• Doublebase may also be applied before washing, showering or having a bath to prevent further drying of the skin.

If additional topical treatments are being used on the same skin areas, Doublebase should be applied between these applications.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

None.

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 Doublebase 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

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.

5.2 Pharmacokinetic Properties

Because Doublebase 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

No relevant information additional to that contained elsewhere in this SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

500 g plastic bottle with pump dispenser or 100 g plastic laminate tube with screw cap.

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)

00173/0183.

9. Date Of First Authorisation/Renewal Of The Authorisation

21 March 2006.

10. Date Of Revision Of The Text

July 2006.