Search for:

Search Medicine or Company Name Search Full Document

Advanced Search

Almirall Limited
4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK Telephone: +44 (0) 207 160 2500 Fax: +44 (0) 208 756 3888 WWW: http://www.almirall.com Medical Information Direct Line: 0800 0087399 Medical Information e-mail: almiralldata@professionalinformation.co.uk Customer Care direct line: +44 (0) 207 160 2500 Medical Information Fax: +44 (0) 1748 828 801 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 04/11/2009

SPC	Balneum Bath Oil

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Balneum

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Soya oil, 84.75% w/w

Go to top of the page

3. PHARMACEUTICAL FORM

Oily liquid for external use.

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

Dry skin conditions including those associated with dermatitis and eczema.

Go to top of the page

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.

Go to top of the page

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

Go to top of the page

4.4 Special warnings and precautions for use

None.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Go to top of the page

4.6 Pregnancy and lactation

Not known.

Go to top of the page

4.7 Effects on ability to drive and use machines

Not applicable.

Go to top of the page

4.8 Undesirable effects

None.

Go to top of the page

4.9 Overdose

Not applicable.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

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.

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable.

Go to top of the page

5.3 Preclinical safety data

Not applicable.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

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.

Go to top of the page

6.2 Incompatibilities

None.

Go to top of the page

6.3 Shelf life

HDPE bottle - 5 years

Foil Laminate sachet - 5 years

Blister pack (20ml) - 2 years

Go to top of the page

6.4 Special precautions for storage

None.

Go to top of the page