DERMOL CREAM

Active substance: LIQUID PARAFFIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Dermol Cream PIL JP30_12_2.qxd:1

23/11/12

15:59

Page 1

PA C K A G E L E A F L E T
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.
Take special care when using this product:
• For patients with very sensitive skin, it is generally a good idea to start any new treatment
on a small test area first, in case any side effect occurs (see Section 4 below). This is
especially important when treating the face or young children. Thereafter, treatments
may be applied more generously, as required.
• Avoid getting it in the eyes, especially when using it on the face.
• When used as a soap substitute in the bath or shower the product can make the surface
slippery, so be careful to avoid slipping over when getting into and out of your shower or
bath (eg by using a shower or bath mat).
Using other medicines
This product is not known to affect, or to be affected by, other medicines.
Pregnancy and breast-feeding
This product can be used during pregnancy and whilst breast-feeding. The ingredients have
been in widespread use in this and similar preparations for many years, without reports of
problems. However, safety trials have not been conducted.
Important information about one of the ingredients of Dermol Cream
The product contains cetostearyl alcohol. This ingredient may cause local skin reactions
(eg contact dermatitis) in a small number of sensitive people. If you have been told by your
doctor that you are sensitive to cetostearyl alcohol, please talk to your doctor before using
this product.
Use it only on the skin. For maximum benefit you should use it on a regular basis and as
often as required.
Before using the 500 g bottle, turn the top of the pump dispenser anti-clockwise to unlock it.
After unlocking, you will need to press down the pump dispenser several times to prime the
pump before any product is dispensed.
The same instructions apply for all age groups:For use as a leave-on application:
• Apply Dermol Cream to the affected areas.
• Gently smooth into the skin.
• If necessary, allow time for any excess to soak in. Do not rub the skin vigorously.
continued…
Prints: PMS 323

Flat size: 154mm x 330mm

JP30/12/2 201099

3. HOW TO USE DERMOL CREAM

Dermol Cream PIL JP30_12_2.qxd:1

23/11/12

15:59

Page 2

• Reapply as often as required.
• If you are applying another treatment to the same areas of skin as Dermol Cream,
try to avoid mixing the two products. This can be achieved by applying the treatments
alternately, leaving sufficient time to allow the previous application to soak in.
For use as a soap substitute
• Use Dermol Cream to wash with instead of your ordinary soap or shower gel.
It will not foam or lather like ordinary cosmetic products.
• After washing, bathing or showering, pat the skin dry with a soft towel (avoid rubbing
as this can make dry skin conditions worse).
If you forget to use Dermol Cream
Do not worry if you occasionally forget to use it, just carry on using the product as described
the next time you require it.
If the product gets into the eyes
The product may cause irritation if it gets into the eyes. Rinse the eyes with plenty of water.
If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists,
seek medical advice.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dermol Cream can cause side effects, although not everybody gets them.
This product has been specially designed for use on dry or problem skin areas anywhere on
the body, but in some very rare cases it can cause local skin reactions (involving redness,
irritation and/or itching). These very rare skin reactions may become more significant where
associated with excessive use as a leave-on application in areas of folded skin such as the
groin or in the nappy area.
Stop using this cream and tell your doctor or pharmacist:
• If your skin condition seems to look or feel worse.
• If any of the side effects become unacceptable, or you notice any other side effects not
mentioned in this leaflet.
If you swallow Dermol Cream
If you accidentally swallow the product and you then feel unwell, seek medical attention.
Do not attempt to cause vomiting.

5. HOW TO STORE DERMOL CREAM
• Keep out of reach and sight of children.
• Do not use Dermol Cream after the expiry date shown on the container and carton.
The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Always replace the cap after use.
• In the case of the 500 g bottle, it is advisable to turn the top of the pump dispenser
clockwise to lock it.

6. FURTHER INFORMATION
What Dermol Cream contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/w), chlorhexidine
dihydrochloride (0.1% w/w), liquid paraffin (10% w/w) and isopropyl myristate (10% w/w).
The other ingredients are cetostearyl alcohol, glycerol, macrogol cetostearyl ether
(cetomacrogol 1000), phenoxyethanol, disodium phosphate dodecahydrate, sodium
dihydrogen phosphate dihydrate and purified water.
What Dermol Cream looks like and contents of the pack
• The product is a white, non-greasy cream that contains no dye or fragrance.
• The product is available in a plastic bottle containing 500 g or in a plastic tube containing
100 g. (30 g packs are also available to the medical and allied professions).
The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is Fleet Laboratories Ltd, 94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last revised in November 2012.

7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Dermol Cream, 00173/0171.
This is a service provided by the Royal National Institute of Blind People (RNIB).

Prints: PMS 323

Flat size: 154mm x 330mm

JP30/12/2 201099

• Emollients help soften, moisturise and protect the skin. They play a central role in the
treatment and management of dry skin conditions. For maximum effect, they should be
applied regularly and as often as needed.
• When bathing, try to use warm, not hot, water and avoid staying in the bath for long
periods. This could make dry skin conditions worse.
• Try to avoid using normal soaps or shower products (even those labelled “moisturising”).
This is because they tend to dry and irritate the skin. Avoid using products containing
fragrances, as these can also cause skin problems. You should try to use a fragrance-free
emollient “soap substitute” instead. This type of product will not foam or lather but will be
better for your dry skin condition.
• Breaking the itch-scratch cycle.
Some dry skin conditions like eczema and dermatitis are itchy, and can be quite sore.
Although scratching relieves the itching for a short while, it further damages the skin. Badly
scratched skin easily gets infected. This makes it itchier and the urge to scratch becomes
even greater. It is better if scratching can be avoided by reducing the itching. The regular
use of emollients or moisturisers can help with this.
• You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support
group such as the National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri)
for information about your skin condition.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)