This information is intended for use by health professionals

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 6.1.

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.

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 Fertility, 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.

Reporting of suspected adverse reactions

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

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

Trolamine

Phenoxyethanol

Macrogol cetostearyl ether (cetomacrogol)

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

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

HDPE bottle (25 g) with polypropylene flip top cap.

Polyethylene laminate tube (25 g) with polypropylene screw cap.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Hertfordshire, SG4 7QR

UK

8. Marketing authorisation number(s)

PL 00173/0196

9. Date of first authorisation/renewal of the authorisation

06/12/2004 / 25/11/2009

10. Date of revision of the text

20/11/2019