- Approval Id
- 01769cb61e4d3a3d
- Drug Approval Emc Name
- Cetraben Emollient Bath Additive / Cetraben Bath Additive
- Drug Name
- Cetraben Emollient Bath Additive / Cetraben Bath Additive
- Company Name
- Genus Pharmaceuticals
- Company Address
- Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
- Company Telephone
- +44 (0)1484842217
- Company Medical Info Direct Line
- +44 (0)1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44 (0)1484 848200
- Company Medical Info Fax
- +44 (0)1484 848164
- Atc Code
- D02AX
- Legal Category
- General Sales List
- Authorisation Holder
- Genus Pharmaceuticals
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Authorisation Number
- PL 06831/0260
- Authorisation Date
- 22/03/2007
- Instruction Authorisation Holder
- Genus Pharmaceuticals
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Instruction Authorisation Number
- PL 06831/0260
- Instruction Authorisation Date
- 22/03/2007
- Instruction Composition
- Light Liquid Paraffin 82.8% w/w
For excipients see section 6.1
- Instruction Dosage Form
- Bath additive
Cetraben Emollient Bath Additive is a clear liquid with a faint odour.
- Instruction 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 ingredients4.4 Special warnings and precautions for use
Allergy to any of the ingredients.
Care when entering or leaving the bath
Avoid contact with eyes.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
No special precautions required4.7 Effects on ability to drive and use machines
None4.8 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.
- Instruction Pharmacology
- 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 skin5.3 Preclinical safety data
Not applicable
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
C-12-13-Pareth-3
Medium chain triglycerides6.2 Incompatibilities
Not applicable6.3 Shelf life
48 months6.4 Special precautions for storage
Do not store above 25°C6.5 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
- Instruction Content
- ## Composition
Light Liquid Paraffin 82.8% w/w
For excipients see section 6.1
## Pharmaceutical Form
Bath additive
Cetraben Emollient Bath Additive is a clear liquid with a faint odour.
## 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 ingredients4.4 Special warnings and precautions for use
Allergy to any of the ingredients.
Care when entering or leaving the bath
Avoid contact with eyes.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
No special precautions required4.7 Effects on ability to drive and use machines
None4.8 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.
## 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 skin5.3 Preclinical safety data
Not applicable
## Pharmaceutical Particulars
6.1 List of excipients
C-12-13-Pareth-3
Medium chain triglycerides6.2 Incompatibilities
Not applicable6.3 Shelf life
48 months6.4 Special precautions for storage
Do not store above 25°C6.5 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
