Chilblain Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chilblain Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient % w/w
Benzyl alcohol Ph Eur 7.5
Eucalyptus Oil Ph Eur 1.0
3. PHARMACEUTICAL FORM
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.
4.3. Contra-Indications
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. Interactions with other Medicinal Products and other Forms of Interaction
None known.
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 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.
4.9. Overdose
Excessive application of the product may lead to excessive reddening of the skin.
Treatment if necessary need only be symptomatic.
PHARMACOLOGICAL PROPERTIES
5
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. 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.
6 PHARMACEUTICAL PARTICULARS
6.1. 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
6.2. Incompatibilities
None.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 250C
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. Instructions for use and handling
None.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC
Nottignham
NG2 3AA
8. 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
10 DATE OF REVISION OF THE TEXT
January 2015