This information is intended for use by health professionals

1. Name of the medicinal product

Chilblain Cream

2. Qualitative and quantitative composition

Active ingredient

%w/w

Benzyl alcohol

Eucalyptus Oil

7.5

1.0

3. Pharmaceutical form

Cream

A 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.

4.3 Contraindications

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

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.

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

6.2 Incompatibilities

None

6.3 Shelf life

36 months

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

None

7. Marketing authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0132

9. Date of first authorisation/renewal of the authorisation

First authorisation: 10 November 1971

Last renewal: 25 July 2002

10. Date of revision of the text

30 November 2016