1. Name Of The Medicinal Product
Cetraben Emollient 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 capful 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 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.
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.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Genus Pharmaceuticals
Park View House
65 London Road
Newbury
Berkshire
RG14 1JN
8. Marketing Authorisation Number(S)
PL 06831/0260
9. Date Of First Authorisation/Renewal Of The Authorisation
10 August 2001 / 22 March 2007
10. Date Of Revision Of The Text
7 July 2011
No comments:
Post a Comment