Dermol Wash cutaneous emulsion

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Preparatomtale Preparatomtale (SPC)
31-03-2023

Aktiv ingrediens:

Benzalkonium chloride; Chlorhexidine hydrochloride; Liquid paraffin; Isopropyl myristate

Tilgjengelig fra:

Dermal Laboratories Ltd

ATC-kode:

n/a

INN (International Name):

Benzalkonium chloride; Chlorhexidine hydrochloride; Liquid paraffin; Isopropyl myristate

Dosering :

1mg/1gram ; 1mg/1gram ; 25mg/1gram ; 25mg/1gram

Legemiddelform:

Cutaneous emulsion

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Never Valid To Prescribe As A VMP

Produkt oppsummering:

BNF: 13020101; GTIN: 5016379157004

Informasjon til brukeren

                                PACKAGE LEAFLET
_Information for the user_
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
Ask your doctor, nurse or pharmacist if you need more information or
advice.
IN THIS LEAFLET:
1. What Dermol Wash is and what it is used for
2. Before you use Dermol Wash
3. How to use Dermol Wash
4. Possible side effects
5. How to store Dermol Wash
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT DERMOL WASH IS AND WHAT IT IS USED FOR
•
Dermol Wash is a moisturising, protective and antiseptic soap
substitute for you to use
whenever you wash. It has been developed for use instead of soaps
(bars and liquids) and
cleansers, both of which may irritate dry skin.
•
Dermol Wash can also be used as a leave on treatment, re-applied after
washing and drying.
•
It helps treat and prevent dry and itchy skin conditions. Common
examples include;
– occupational hand dermatitis (due to frequent hand-washing, or
repeated contact with water
or chemicals such as cleaning or hair products)
– eczema and other types of dermatitis
– psoriasis (scaly, pink patches of skin)
– elderly pruritus (itchy skin due to ageing)
– ichthyosis (unusually scaly skin)
•
ALL AGE GROUPS can use Dermol Wash, including babies.
•
The ACTIVE INGREDIENTS in this product are isopropyl myristate and
liquid paraffin (which
are EMOLLIENTS), and benzalkonium chloride and chlorhexidine
dihydrochloride (which are
ANTIMICROBIALS).
•
This soap substitute is specially designed to be non-foaming and is
fragrance free. When used
as part of your normal washing routine, it helps to:
– cleanse, soften, moisturise and protect your skin by trapping in
moisture and restoring the
normal protective function of the skin
– prevent the skin-drying and irritant effects that can be caused by
washing and by the soaps,
foaming additives and fragrances used in ordinary cleansing products
– combat bacteria present on your skin that can make eczema wors
                                
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Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dermol Wash Cutaneous Emulsion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid paraffin
2.5% w/w
Isopropyl myristate
2.5% w/w
Benzalkonium chloride
0.1% w/w
Chlorhexidine dihydrochloride
0.1% w/w
Excipients with known effect:
Cetostearyl alcohol
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Cutaneous emulsion
White, non-greasy cutaneous emulsion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An antimicrobial emollient for the management of dry and pruritic skin
conditions,
especially
eczema
and
dermatitis.
Dermol
Wash
Cutaneous
Emulsion is suitable for direct application and for use as a soap
substitute.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults, children and the elderly. For cutaneous use only.
_ _
_For use as a soap substitute _
Use as a cleanser at the sink or to wash with in the bath or shower,
instead of
ordinary soap or shower gel. Pat the skin dry using a soft towel
(avoid rubbing
as this can irritate the skin).
The product may also be used in a similar way for frequent hand
washing.
_ _
_For application to the skin (eg after washing) _
Apply to the affected areas as required.
4.3
CONTRAINDICATIONS
Do not use in cases of known sensitivity (especially generalised
allergic reaction) to
any of the ingredients (see sections 4.4 and 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
Local skin reactions (e.g. contact dermatitis) to any of the
ingredients are rare but
possible in sensitive people.
There are literature reports of chlorhexidine compounds inducing
hypersensitivity,
including anaphylactic shock. The prevalence of this is not known, but
is likely to be
very rare. Dermol Wash Cutaneous Emulsion should not be administered
to anyone
with a possible history of allergic reaction to a chlorhexidine
compound (see sections
4.3 and 4.8).
Dermol Wash Cutaneous Emulsion contains cetostearyl alcohol which may
cause
local skin reactions (e.g. contact dermatitis).
Instruct pati
                                
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