Summary of Product Characteristics (SmPC) - Cetomacrogol cream BP 1988 Formula A.
1 NAME OF THE MEDICINAL PRODUCT
Cetomacrogol Cream BP 1988 Formula A
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Macrogol Cetostearyl Ether 22 1.8% w/w
3 PHARMACEUTICAL FORM
Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For external application for use as an emollient, and for use as a diluent in medicinal external preparations.
4.2 Posology and method of administration
Topical
Recommended dose and dosage schedule
To be used as prescribed by a registered medical practitioner or counter prescribed by a
registered pharmacist.
The product is suitable for use by adults, children and the elderly. Dosage: as prescribed by the medical practitioner or pharmacist.
4.3 Contraindications
Sensitivity to chlorocresol.
4.4 Special warnings and precautions for use
For external use only.
Keep all medicines away from children.
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.
Store below 25°C. Do not allow to freeze.
The diluted cream should be used within 2 weeks of preparation.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
No special precautions regarding this vehicle.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
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
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The product has an emollient effect.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetostearyl alcohol
Chlorocresol
Liquid Paraffin
Paraffin White Soft
Water Purified
6.2 Incompatibilities
Macrogol cetostearyl ether is incompatible with phenols and reduces the antibacterial activity of quaternary ammonium compounds.
6.3 Shelf life
500g: 36 months unopened.
6.4 Special precautions for storage
Store below 25°C. Do not allow to freeze.
6.5 Nature and contents of container
500g: polypropylene jar and lid.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31.05.74 / Last renewed 25.11.98
10 DATE OF REVISION OF THE TEXT
11/09/2019