Active substance(s): BENZYL ALCOHOL / EUCALYPTUS OIL / METHYL NICOTINATE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Benzyl alcohol Ph Eur Eucalyptus Oil Ph Eur % w/w 7.5 1.0
PHARMACEUTICAL FORM Cream
Therapeutic Indications To soothe and heal broken and unbroken chilblains. For topical administration.
Posology and Method of Administration Cream to be applied to affected area and rubbed gently into the skin.
Contra-Indications Known Hypersensitivity to any of the ingredients.
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. Interactions with other Medicinal Products and other Forms of Interaction None known.
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.
Effects on Ability to Drive and Use Machines No adverse effects known.
Undesirable Effects Rarely hypersensitivity reactions.
Overdose Excessive application of the product may lead to excessive reddening of the skin. Treatment if necessary need only be symptomatic.
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.
Pharmacokinetic Properties No data available.
Pre-clinical 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.
List of excipients Purified water Natrosol 250H Propylene glycol Triethanolamine Methyl parahydroxybenzoate Stearic acid toilet Cetyl alcohol Glyceryl monostearate 40-50 Wool fat Arachis oil Silicone fluid F111/20 Butylated hydroxyanisole Propyl parahydroxybenzoate
Shelf life 36 months.
Special precautions for storage Do not store above 250C
Nature and contents of container A collapsible, internally lacquered, aluminium tube with an HDPE or polypropylene wadless cap. Pack size: 35g
Instructions for use and handling None.
MARKETING AUTHORISATION HOLDER The Boots Company PLC Nottignham NG2 3AA
MARKETING AUTHORISATION NUMBER PL 00014/0132
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION First authorisation: 10 November 1971 Last renewal: 22 July 1992
DATE OF (PARTIAL) REVISION OF THE TEXT June 2004