Summary of Product Characteristics (SmPC) - Doublebase Dayleve gel
1 NAME OF THE MEDICINAL PRODUCT
Doublebase Dayleve 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 long-lasting, 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 Dayleve Gel may also be used as an adjunct to other topical treatments.
4.2 Posology and method of administration
For external use only.
For adults, the elderly, infants and children.
- Apply Doublebase Dayleve Gel to the affected areas morning and night, or as often as necessary.
For best results use a few gentle strokes to smooth Doublebase
Dayleve Gel 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 Dayleve Gel 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 Dayleve Gel 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
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 Dayleve 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
ATC Code: D02AX
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
The product is formulated to provide long-lasting skin hydration. Because Doublebase Dayleve 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
Povidone
Carbomer
Sorbitan Laurate
Trolamine
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
PVC BOTTLE (500 g) with polypropylene METERING PUMP
Polyethylene laminate tube (25 g and 100 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 00173/0199
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/03/2007
10 DATE OF REVISION OF THE TEXT
20/12/2019