Balneum Bath Oil

1. Name Of The Medicinal Product

Balneum

2. Qualitative And Quantitative Composition

Soya oil, 84.75% w/w

3. Pharmaceutical Form

Oily liquid for external use.

4. Clinical Particulars

4.1 Therapeutic Indications

Dry skin conditions including those associated with dermatitis and eczema.

4.2 Posology And Method Of Administration

Topical

The liquid should be added to bath water.

For full bath (approx. 100 litres)	20ml (1 measure)
For child's bath (approx. 25 litres)	5ml (1/4 measure)
For partial bath (approx. 5 litres)	2.5ml (1/8 measure)

In particularly dry skin, 2-3 times the above quantities can be used

Generally, 2-3 baths should be taken weekly. For babies and infants a daily bath is recommended.

4.3 Contraindications

• Hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1 .

• Hypersensitivity to peanut or soya.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Balneum was developed in response to the need for a suitable non-irritant cleansing agent for patients with eczema. As the skin in this condition requires the application of large amounts of fat, cleansing properties as well as greasing properties were combined. Balneum is a mixture of plant oils having a high proportion of unsaturated fatty acid (linolic acid up to 60%). The emulsifier used is a mixture of fatty acid amides with aliphatic alcohol and readily dispersible polyoxyethylene lauryl ester. Butylhydroxytoluene is added as an antioxidant.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyoxyethylene lauryl ether (4mol EO), oleic acid diethanolamide, perfume oil DV5171, propylene glycol, butylated hydroxytoluene, ascorbyl palmitate, citric acid monohydrate.

6.2 Incompatibilities

None.

6.3 Shelf Life

HDPE bottle - 5 years

Foil Laminate sachet - 5 years

Blister pack (20ml) - 2 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Container: HDPE bottle with polyethylene or polypropylene cap and with or without LDPE dispensing insert.

Contents: Each bottle contains one of the following amounts; - 20ml, 95ml, 100ml, 150ml, 200ml,225ml, 250ml, 300ml, 500ml, 2x500ml, 600ml, 1000ml.

Also

Container: Foil laminate sachets.

Contents: Each sachet contains one of the following amounts: 10ml, 20ml.

Also

20ml blister pack, consisting of blister foil (PET/PB) and cover foil (PET/aluminum/PE)

6.6 Special Precautions For Disposal And Other Handling

None.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465,

Reinbek

Germany

8. Marketing Authorisation Number(S)

PL 33016/0008

9. Date Of First Authorisation/Renewal Of The Authorisation

31 July 1998

10. Date Of Revision Of The Text

17 November 2011