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UREA10% W/W CREAM

Active substance(s): UREA / UREA

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PATIENT INFORMATION LEAFLET
Urea 10% w/w Cream
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to use
Urea 10% w/w Cream carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
The information in this leaflet has been divided into the following sections:
1.
2.
3.
4.
5.
6.

What Urea 10% w/w Cream is and what it is used for
Check before you use Urea 10% w/w Cream
How to use Urea 10% w/w Cream
Possible side effects
How to store Urea 10% w/w Cream
Further information

1. What Urea 10% w/w Cream is and what it is used for
Urea 10% w/w Cream is an emollient used to treat dry, scaly skin conditions.
The cream helps to soften and moisturise your skin.
Dry skin is caused by a lack of water in the outer layer of skin cells known as
the stratum corneum (top layer of the skin). When this layer becomes dry it
becomes cracked, scaly and sometimes itchy.
The skin dries out when too much water evaporates from its surface. This
increases as we get older, and is made worse by washing, because hot water
and soap can remove the layer of natural oil on the skin.
Urea 10% w/w Cream contains urea, the skin’s natural moisturiser. Urea is a
substance that is found naturally in the stratum corneum. It helps the skin
retain moisture. Water is also normally retained in the stratum corneum by a
thin layer of natural oil (sebum), which slows down evaporation of water from
the skin surface.
The urea in Urea 10% w/w Cream is mixed with white soft paraffin which
forms a layer of oil on the surface of the skin. This oily layer helps prevent
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water from evaporating from the skin’s surface which will reduce irritation,
restore suppleness and improve the appearance of your skin.

2. Check before you use Urea 10% w/w Cream
Do not use Urea 10% w/w Cream:
• if you are allergic (hypersensitive) to urea or any of the ingredients of Urea
10% w/w Cream (see Section 6 Further information).
If the above applies to you, or if you are not sure, speak to your doctor or
pharmacist before you use Urea 10% w/w Cream.
Take special care with Urea 10% w/w Cream
Before you use Urea 10% w/w Cream tell your doctor if:
• you have moist or broken skin.
If any of the above applies to you, or if you are not sure, speak to your doctor
or pharmacist before you use Urea 10% w/w Cream.
Using other medicines
Tell your doctor or pharmacist if you are using or have recently used any other
medicines which are applied to the skin as they may interfere with Urea 10%
w/we Cream.
Please tell your doctor or pharmacist if you are taking or have recently
taken/used any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Urea 10% w/w Cream
Always use Urea 10% w/w Cream exactly as your doctor has told you to. You
should check with your doctor or pharmacist if you are not sure.
Urea 10% w/w Cream is for external use only and should only be applied to
the skin. It should not be used on moist or broken skin.
Using Urea 10% w/w Cream is easy, just follow the instructions below:

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Wash the affected
areas well and rinse
off any traces of soap

dry

apply a suitable
amount of cream
twice daily

Your doctor may tell you to cover this with a special “occlusive” dressing (an
air tight dressing), but this is not usually necessary.
What to do if you use more Urea 10% w/w Cream than you should
Using too much Urea 10% w/w Cream may cause skin irritation (redness,
burning or itching). If this happens to you ask your doctor for advice.
The cream is for external use only and should only be applied to the skin. If
you accidentally swallow the cream this may make you feel sick; drink plenty
of water or milk. You should tell your doctor at once or contact your nearest
accident and emergency department. Show any left-over medicines or the
empty container to the doctor.
If you forget to use Urea 10% w/w Cream
If you forget to use Urea 10% w/w Cream on any occasion, do not worry, just
continue as normal.
Some do’s and dont’s for Urea 10% w/w Cream:
Do
Do
use Urea 10% w/w
wash, rinse and dry
Cream regularly as
affected areas before
directed
applying Urea 10% w/w
Cream

Do
Apply Urea 10% w/w
Cream to the whole of the
affected area - twice daily

Don’t
use Urea 10% w/w
Cream if you’ve had a
past reaction to it or any
of its ingredients

Don’t
worry if you occasionally
forget to use Urea 10%
w/w Cream - continue
using it as before

Don’t
use Urea 10% w/w
Cream on moist or
broken skin

If you have any further questions on the use of this product, ask your doctor,
nurse or pharmacist.

4. Possible side effects

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Do not worry. Like all medicines, Urea 10% w/w Cream can cause side
effects, although not everyone gets them.
Some people experience local irritation when they apply Urea 10% w/w
Cream. If you notice this or any other unusual effect, tell your doctor.
If you use Urea 10% w/w Cream as your doctor tells you, it is unlikely to
cause side effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via:
UK:
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
IE:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie, E-mail:
medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Urea 10% w/w Cream
Keep out of the reach and sight of children.
Do not use Urea 10% w/w Cream after the expiry date which is stated on the
carton and on the base of the tube. The expiry date refers to the last day of
that month.
Do not store Urea 10% w/w Cream above 30ºC.
Do not use Urea 10% w/w Cream if you notice a change in the colour or feel
of the cream.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist on how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Further information
What is in Urea 10% w/w Cream?
The active ingredient in this medicine is urea 10% w/w contained in white soft
paraffin.
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The other ingredients are isopropyl myristate, maize starch, glyceryl
tribehenate, palmitic acid, sorbitan laurate and polyoxyethylene fatty
glyceride.
What Urea 10% w/w Cream looks like and contents of the pack
Urea 10% w/w Cream is a smooth, unperfumed, non greasy and off white
cream.
Urea 10% w/w Cream comes in tubes of 30g (grams) and 100g. A 30g tube
of Urea 10% w/w Cream contains 3g of urea and a 100g tube contains 10g of
urea.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder is: Alliance Pharmaceuticals Ltd, Avonbridge
House, Chippenham, Wiltshire, SN15 2BB, UK.
Urea 10% w/w Cream is manufactured by: Laboratoires Chemineau, 93 Route
de Monnaie, BP 16, 37210 Vouvray, France.
The information in this leaflet applies only to Urea 10% w/w Cream. If you
have any questions or you are not sure about anything, ask your doctor or a
pharmacist.
This leaflet was last approved: January 2017.
Alliance, Alliance Pharmaceuticals and associated devices are registered
trade marks of Alliance Pharmaceuticals Ltd.
© Alliance Pharmaceuticals Ltd 2017

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Expand Transcript

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.

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