Balneum Plus

Bath oil

Balneum Plus is a bath oil the active ingredients of which have emollient and local anaesthetic properties and provide relief of pruritus. It is recommended for the treatment of dry skin conditions including those associated with dermatitis and eczema where severe pruritus is also experienced.

After shaking the bottle, Balneuln Plus should be added to the bath water and mixed well.

Frequency and duration of the application should be adjusted according to the type and severity of the condition, adults should use the bath oil frequently (at least 3 times per week) whilst neonates and infants should be treated daily.

Dosage

The following quantities are recommended: (If the skin requires considerable moisturising, 2-3 times these quantities can be used)

Adults (including the elderly)

For full bath (~100L) 20ml

For partial bath (~5L) 2.5ml

Neonates and children

For bath (~25L) 5ml

For neonates and children daily application is recommended.

Method of administration

A partial bath may be required when condition is localised e.g. the arm.

Balneum Plus can also be used in the shower. In this case the preparation should first be evenly applied over the body without dilution. Subsequently the excess is removed under the shower. Soap, which would remove the desired oil film on the skin, should not be used.

Excessive rinsing with water after the bath counteracts the therapeutic action of Balneum Plus.

After a bath or shower the skin should only be lightly dabbed with a towel. Vigorous wiping and rubbing decreases the therapeutic effect.

Sensitivity to any of the ingredients.

As Balneum Plus deposits a film of oil over the skin, care should be taken to avoid slipping, especially in the bath or shower.

Contact with the eyes should be avoided and if it occurs the eyes should be washed out with copious amounts of clean water.

Ingestion of the bath oil should be avoided

None known.

No special precautions are recommended.

None known.

None known.

In the event of oral ingestion the occurrence of symptoms is very unlikely owing to the low toxicity of the ingredients. No specific antidote or treatment is recommended.

Lauromacrogols (polidocanol) is a local anaesthetic and has an antipruritic action. It is an effective infiltration and conduction anaesthetic.

Polidocanol diffuses from skin and mucous membranes to the sensory nerves and therefore has an alleviating effect on the sensation of itch.

Although it has been suggested that local anaesthetics in general have little effect over the intact stratum corneum because of their inability to penetrate this barrier; this seems to apply only to the pure substance without a fatty base.

None relevant to the prescriber which are not mentioned elsewhere in this Summary of Product Characteristics.

Ascorbyl palmitate

Glyceryl stearate citrate

Propylene glycol

Perfume oil

None known.

3 years

None stated.

Balneum Plus is supplied in high density polyethylene bottles in the following sizes: 20ml, 95ml, 100ml, 150ml, 200ml, 225ml, 250ml, 300ml, 500ml, 2x500ml, 600ml and l000ml and also in l0ml and 20ml foil laminate sachets and 20 ml polyethylene/foil blisters.

None stated.

ADMINISTRATION DETAILS

Hermal Kurt Herrmann GmbH & Co OHG

Scholtzstrasse 3

D-21465,

Reinbek

Germany

PL 04758/0012

31 July 1998

8^th October 2009