Balneum Plus Cream

Cream.

A white smooth cream.

For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.

Adults, the elderly and children: Balneum Plus Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response. For external use only.

Patients with known hypersensitivity to any of the ingredients. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.

Balneum Plus Cream may cause irritation if applied to broken or inflamed skin.

None known.

For Balneum Plus Cream no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.

None.

Balneum Plus Cream has been reported to cause a burning sensation, erythema, pruritus or the formation of pustules, aggravation of eczema if applied to inflamed skin areas. Contact allergy has also been reported.

Not applicable

Pharmacotherapeutic group: Antipruritics incl. antihistamines, anaesthetics etc.

ATC code: D 04 AX

Urea is a physiological product derived from human protein metabolism. It is found naturally in the skin and when applied topically it can increase the horny layer's capacity to retain water. Balneum Plus Cream has been shown to increase skin hydration and when used as recommended provides hydration for 24 hours.

Patients with eczema and psoriasis have been shown to have decreased levels of urea in their skin. Urea is not allergenic and is well-tolerated at a concentration of 5%.

Lauromacrogols have the properties of a topical anaesthetic and have an antipruritic effect. The local tolerability of lauromacrogols is good.

Balneum Plus Cream has also been shown to increase the lipid content of the epidermis thus soothing and smoothing the skin.

After twice-daily application for 4 weeks to non-infected eczematous lesions, in addition to an improvement in the clinical condition, use of Balneum Plus Cream was associated with a significant reduction in total bacteria and Staph. aureus counts. A reduction in Staph. aureus count (p0.01) was observed on eczematous skin from Day 1 (148 organisms/cm²) to Day 29 (11.8 organisms/cm²). However, no bactericidal or bacteriostatic effects have been tested for.

Little urea is absorbed after topical application. It is mainly excreted in the urine, and to a lesser extent in perspiration.

There is no evidence of systemic availability of lauromacrogols after topical administration.

No specific studies have been performed with Balneum Plus Cream. Urea and lauromacrogols have been used therapeutically for many years in humans. Information from animal studies are unlikely to provide any further relevant information.

Dimethicone

Phenyl dimeticone

Liquid paraffin

Cetylpalmitate

Stearic palmitic acid

Octyldodecanol

Glycerol 85%

Polvsorbate

Carbomer

Trometamol

Benzyl alcohol

Purified water

Not applicable.

24 months.

Do not store above 25°C.

Aluminium tubes with double internal lacquer of epoxy phenol resin and closure made of polyethylene. Content: 10g, 35g, 50g, 75g and 100g.

Plastic pump dispensers. Content: 175g, 180g, 185g, 190g, 200g and 500g.

No special requirements

Almirall Hermal GmbH

Scholtzstrasse 3

Postfach 1228 Reinbek

Hamburg

D-21465

Germany

PL 33016/0010

31^st July 1998

06^th October 2010