This information is intended for use by health professionals

1. Name of the medicinal product

Cetraben Emollient Bath Additive

Cetraben Bath Additive

2. Qualitative and quantitative composition

Light Liquid Paraffin 82.8% w/w

For excipients see section 6.1

3. Pharmaceutical form

Bath additive

Cetraben Emollient Bath Additive is a clear liquid with a faint odour.

4. Clinical particulars
4.1 Therapeutic indications

Cetraben Emollient Bath Additive is an emollient, moisturising and protective oil for the symptomatic relief of red, inflamed, damaged, dry or chapped skin, especially when associated with endogenous or exogenous eczema.

4.2 Posology and method of administration

Cetraben Emollient Bath Additive should be added to a warm water bath or applied to wet skin before showering.

Bath:

Adults:

Add one/two capfuls to a warm water bath

Children:

Add half/one capfuls to a warm water bath

Shower:.

Apply lightly using a wet sponge

4.3 Contraindications

Hypersensitivity to any of the ingredients

4.4 Special warnings and precautions for use

Allergy to any of the ingredients.

Care when entering or leaving the bath

Avoid contact with eyes.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

No special precautions required

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Very rarely, mild skin reactions have been seen

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.

4.9 Overdose

No cases of overdose have been reported. Patients should be advised that if they accidentally swallow Cetraben Emollient Bath Additive, they should talk to their doctor or pharmacist at once.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC Code: D02AX (Other Emollients and Protectives)

The ingredients of Cetraben Emollient Bath Additive have emollient, moisturising and protective properties.

5.2 Pharmacokinetic properties

Cetraben Emollient Bath Additive acts only on the skin

5.3 Preclinical safety data

Not applicable

6. Pharmaceutical particulars
6.1 List of excipients

C-12-13-Pareth-3

Medium chain triglycerides

6.2 Incompatibilities

Not applicable

6.3 Shelf life

48 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

PVC bottles containing 500ml, with polypropylene and polyethylene metered dosage caps.

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

Genus Pharmaceuticals

Linthwaite,

Huddersfield,

HD7 5QH, UK

8. Marketing authorisation number(s)

PL 06831/0260

9. Date of first authorisation/renewal of the authorisation

22/03/2007

10. Date of revision of the text

26/01/2018