Dermol cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Liquid paraffin; Isopropyl myristate; Benzalkonium chloride; Chlorhexidine hydrochloride

Available from:

Dermal Laboratories Ltd

ATC code:

D02AX

INN (International Name):

Liquid paraffin; Isopropyl myristate; Benzalkonium chloride; Chlorhexidine hydrochloride

Dosage:

100mg/1gram ; 100mg/1gram ; 1mg/1gram ; 1mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 13020100; GTIN: 5016379156106 5016379156007

Patient Information leaflet

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 Cream is and what it is used for
2. Before you use Dermol Cream
3. How to use Dermol Cream
4. Possible side effects
5. How to store Dermol Cream
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT DERMOL CREAM IS AND WHAT IT IS USED FOR
•
Dermol Cream 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 Cream, 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 CREAM
DO NOT USE Dermol Cream if you are ALLERGIC (hypersensitive) to
benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate,
or any of the other ingredients
of Dermol Cream listed in Section 6.
WARNINGS AND P

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dermol Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid paraffin
10.0% w/w
Isopropyl myristate
10.0% 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
Cream
White non-greasy topical emulsion
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
An antimicrobial emollient cream for the management of dry and
pruritic skin
conditions, especially eczema and dermatitis. The cream is suitable
for direct
application, and for use as a soap substitute.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Before using the 500g pump bottle, turn the top of the pump dispenser
anti-
clockwise to unlock it.
For adults, the elderly, infants and children.
_For application to the skin _
Apply Dermol Cream to the affected areas as often as necessary.
_For use as a soap substitute _
Dermol Cream may also be used 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 Cream 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 Cream 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, dressing