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Genus Pharmaceuticals
Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
Telephone: +44 (0)1635 568 400
Fax: +44 (0)1635 568 401
Medical Information Direct Line: +44 (0)870 851 0207
Medical Information e-mail: genus@medinformation.co.uk
Customer Care direct line: +44 (0)1635 568 445
Medical Information Fax: +44 (0)1793 710 387

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Summary of Product Characteristics last updated on the eMC: 13/02/2012
SPC Cetraben Emollient Bath Additive


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1. NAME OF THE MEDICINAL PRODUCT

Cetraben Emollient Bath Additive


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin 82.8% w/w

For excipients see section 6.1.


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3. PHARMACEUTICAL FORM

Bath Additive

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


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4. CLINICAL PARTICULARS

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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.


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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 capful to a warm water bath
 Shower:Apply lightly using a wet sponge

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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

No special precautions required.


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4.7 Effects on ability to drive and use machines

None.


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4.8 Undesirable effects

Very rarely, mild skin reactions have been seen.


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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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC Code: D02AX (Other Emollients and Protectives)

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


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5.2 Pharmacokinetic properties

Cetraben Emollient Bath Additive acts only on the skin.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

C-12-13-Pareth-3

Medium chain triglycerides


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

48 months.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

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

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN


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8. MARKETING AUTHORISATION NUMBER(S)

PL 06831/0260


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 August 2001 / 22 March 2007


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10. DATE OF REVISION OF THE TEXT

7 July 2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/13467/SPC/


Active Ingredients/Generics

 
  light liquid paraffin