Summary of Product Characteristics (SmPC) - 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 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 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 25ºC.
Do not freeze.
6.5 Nature and contents of container
HDPE bottle (200g) with polypropylene/silicone valve cap and polypropylene hooked overcap.
HDPE bottle (25g) with polypropylene flip top cap.
Polyethylene laminate tube (25g) with polypropylene screw cap.
6.6 Special precautions for disposal
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
PL 00173/0196
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/12/2004
10 DATE OF REVISION OF THE TEXT
20/11/2019