Dermol 500 lotion

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Benzalkonium chloride; Chlorhexidine hydrochloride; Liquid paraffin; Isopropyl myristate

Dostupné z:

Dermal Laboratories Ltd

ATC kód:

D02AX

INN (Medzinárodný Name):

Benzalkonium chloride; Chlorhexidine hydrochloride; Liquid paraffin; Isopropyl myristate

Dávkovanie:

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

Forma lieku:

Cutaneous emulsion

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Never Valid To Prescribe As A VMP

Prehľad produktov:

BNF: 13020100; GTIN: 5016379150005

Príbalový leták

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 or pharmacist if you need more information or advice.
IN THIS LEAFLET:
1. What Dermol 500 Lotion is and what it is used for
2. Before you use Dermol 500 Lotion
3. How to use Dermol 500 Lotion
4. Possible side effects
5. How to store Dermol 500 Lotion
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT DERMOL 500 LOTION IS AND WHAT IT IS USED FOR
•
Dermol 500 Lotion is an antimicrobial and emollient (softening and
moisturising) treatment
for application to dry or problem skin.
•
It is for use in two ways:
– as a leave-on application
– as a soap-substitute
•
It helps treat and prevent dry and itchy (pruritic) skin conditions,
especially eczema and
dermatitis.
•
ALL AGE GROUPS can use Dermol 500 Lotion, including babies.
•
There are two types of ACTIVE INGREDIENT in this product:
– Benzalkonium chloride and chlorhexidine dihydrochloride are
ANTIMICROBIALS. These
help to:
– combat bacteria present on your skin that can make eczema worse
– prevent infection caused by scratching itchy skin.
– Liquid paraffin and isopropyl myristate are EMOLLIENTS which help
to:
– soften, moisturise and protect your skin by trapping moisture in
the skin and restoring
the normal protective function of the skin
– prevent the skin-drying and irritant effects that can be caused by
washing and bathing
and by the soaps, foaming additives and fragrances used in ordinary
skin cleansing
products.
•
This product can be used in addition to any other emollients or
treatments your doctor or
pharmacist may have given or prescribed for you to treat your dry skin
condition.
2. BEFORE YOU USE DERMOL 500 LOTION
DO NOT USE Dermol 500 Lotion if you are ALLERGIC (hypersensitive) to
benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate,
or any of the other
ingredients of Derm

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dermol 500 Lotion
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. The lotion 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 application to the skin _
Apply the lotion to the affected areas as required.
Massage into the skin, until absorbed.
_For use as a soap substitute _
Use as a cleanser in the bath or shower, or for other toiletry
purposes, instead
of ordinary soap or shower gel.
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 500 Lotion 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 500 Lotion contains cetostearyl alcohol which may cause local
skin reactions
(e.g. contact dermatitis).
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 cloth