This information is intended for use by health professionals
1. Name of the medicinal product
2. Qualitative and quantitative composition
|Benzyl alcohol Eucalyptus Oil||7.5 1.0|
3. Pharmaceutical form
CreamA smooth, creamy-white cream.
4. Clinical particulars
4.1 Therapeutic indications
To soothe and heal broken and unbroken chilblains.For topical administration.
4.2 Posology and method of administration
Cream to be applied to affected area and rubbed gently into the skin.
Known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
If symptoms persist, consult your doctor.For external use only.Keep all medicines out of the reach of children.Chilblain Cream contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Chilblain Cream.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
The safety of chilblain cream during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Rarely hypersensitivity reactions.
Reporting of suspected adverse reactionsReporting 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.
Excessive application of the product may lead to excessive reddening of the skin. Treatment if necessary need only be symptomatic.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Eucalyptus oil has an irritant and rubefacient action on intact skin, providing improved local circulation and a feeling of warmth.Benzyl alcohol has a weak local anaesthetic activity and reduces the discomfort associated with chilblains.
5.2 Pharmacokinetic properties
No data available.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Purified water Hydroxyethylcellulose Propylene glycol Triethanolamine Methyl hydroxybenzoate Stearic acid Cetearyl alcohol Glyceryl monostearate 40-50 Wool fat Arachis oil Dimeticone Butylated hydroxyanisole Propyl hydroxybenzoate
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
A collapsible, internally lacquered, aluminium tube with an HDPE or polypropylene wadless cap.Pack size: 35g
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
The Boots Company PLCNottinghamNG2 3AA
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
First authorisation: 10 November 1971Last renewal: 25 July 2002
10. Date of revision of the text
30 November 2016