Doublebase Emollient Shower Gel

1. Name Of The Medicinal Product

DOUBLEBASE™ EMOLLIENT SHOWER GEL

2. Qualitative And Quantitative Composition

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

For excipients, see section 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 Emollient Shower Gel may also be used as an adjunct to other topical treatments.

4.2 Posology And Method Of Administration

For adults, the elderly and children, who normally shower. For external use only. Use regularly and as often as necessary.

Doublebase Emollient Shower Gel may be applied before, during or after showering, with or without a normal cleanser (according to personal preference), to help prevent the drying and irritant effects of normal showering.

Doublebase Emollient Shower Gel can be used in one or more of the following ways:

• Before showering, apply the gel to dry skin areas using a few gentle strokes.

• During showering, apply the gel using a gentle washing action, rinse off any excess and pat the skin dry using a soft towel (avoid rubbing as this can irritate the skin). If a cleanser is to be used, apply the emollient gel afterwards.

• After showering, apply the gel to dry skin areas, using a few gentle strokes across the skin in the same direction as hair growth. If necessary, allow time for any excess to soak in. Do not rub vigorously.

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 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 Doublebase Emollient Shower Gel 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 Emollient Shower Gel 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; 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

Plastic bottle (200g) with polypropylene/silicone valve cap and plastic hooked overcap.

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)

00173/0196.

9. Date Of First Authorisation/Renewal Of The Authorisation

25 November 2009.

10. Date Of Revision Of The Text

September 2008.