Balneum
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Lot:
Exp:
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. corticosteroides, 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.
For the treatment of itching and dry skin associated with eczema, dermatitis and scaling skin conditions
Do not use after expiry date (see top of the label, refers to the end of that month.) Shelf life after 1st opening: 6 months.
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: 05/2013
(^Almirall
Licence holder and Manufacturer:
Almirall Hermal GmbH
ScholtzstraBe 3, 21465 Reinbek, Germany
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ARTWORK INFORMATION PANEL
Marked trade name: Balneum Plus Cream GB, 500g label
Regulatory text number: m-1-3-1-stand alone PIL
Name:
K. Schnau
PMS
Date:
16/05/2013
