BALNEUM

Active substance: SOYA OIL

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Balneum Plus
Cream

Lot:
Exp:

Balneum Plus
Cream
Urea 5,0 %,
Lauromacrogols 3,0 %

8000xxxx / GB / 0612

For the treatment of itching and
dry skin associated with eczema,
dermatitis and scaling skin conditions

500 g

5 000167 032598

Balneum Plus Cream is an easily absorbed cream containing an ingredient called
lauromacrogols which relieves itching. It has a soothing and softening effect on your
skin and also works by replacing the much needed oils in your dry skin. This helps to
prevent loss of skin moisture. The cream also contains urea. This substance is found
naturally in the skin and helps the skin to retain water. Many people with eczema
and psoriasis have reduced amounts of urea in their skin and Balneum Plus Cream
can help by replacing it. This cream has been shown to increase skin moisture for up
to 24 hours.
The indicated skin conditions worsen when the skin is allowed to become dry.
Do not use:
• If you are allergic (hypersensitive) to urea, lauromacrogols or to any of the ingredients.
• If you are suffering from severe and widespread reddening of the skin.
• If the affected area has suddenly become inflamed or is oozing and/or infected.
• On the breasts immediately prior to breast feeding.
Warnings and precautions: Your medicine may cause irritation if applied to broken
or inflamed skin. Avoid contact to mucous membranes and eyes.
Directions: For external use by adults, the elderly and children. Prior to first use
remove collar and discard. Using clean hands, apply the cream to the affected areas
twice a day until the symptoms have eased. Your doctor will tell you for how long
you need to use the cream. Please tell your doctor or pharmacist if you are using
other medicines. Urea may increase the penetration through the skin barrier of
other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil)
when used at the same time.
Possible side effects: Like all medicines, Balneum Plus Cream can cause side effects,
although not everybody gets them. Treated skin can get worse after using it.
• You may experience a burning sensation, redness, itching or the formation of
pustules or your eczema may get worse if the cream is used on inflamed skin.
If this happens stop using the cream and talk to your doctor or pharmacist.
Do not use after expiry date (see top of the label, refers to the end
of that month.) Do not store above 25°C.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Active Ingredients: urea Ph Eur 5 % w/w , lauromacrogols 3% w/w.
Also contains: dimethicone, phenyl dimethicone, liquid paraffin,
cetyl palmitate, stearic palmitic acid, octyldodecanol, polysorbate,
carbomer, glycerol, benzyl alcohol, trometamol, purified water.
Balneum Plus Cream is a white smooth cream.
PL 33016/0010
Text revised: 09/2013
Licence holder and Manufacturer:
Almirall Hermal GmbH
Scholtzstraße 3, 21465 Reinbek, Germany

33311133
Marked trade name: Balneum Plus Cream GB, 500g label

PROOF:

6
Regulatory text number: m-1-3-1-stand alone PIL

Name:
Date:

Ch. Danker
30/09/2013

PMS

Item Number:

8000XXX5
Version number:

PDS MOCK UP

Colours

DRAWING

293 C
PMS

311 C

PHES-code

xxx 331313
Braille

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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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