Summary of Product Characteristics (SmPC) - 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
For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Gel
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.
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 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.
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
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 E422
Carbomer
Sorbitan Laurate
Trolamine
Phenoxyethanol
Macrogol cetostearyl ether (cetomacrogol)
Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
25g polyethylene laminate tube with polypropylene screw cap: 24 months
200g HDPE bottle with polypropylene/LDPE pump dispenser: 18 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/LDPE pump dispenser.
Polyethylene laminate tube (25 g) 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(S)
PL 00173/0402
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/11/2024
10 DATE OF REVISION OF THE TEXT
15/11/2024