SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Boots Pharmaceuticals Sore Skin Relief Calendula Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains:

9.0% v/w tincture of Calendula flowers (Calendula officinalis L.)(1:10)

Extraction solvent: Ethanol 3.0 %v/w

Also contains Cetostearyl alcohol, propylhydroxybenzoate (E216) and methyl parahydroxybenzoate (E218). (See section 4.4. Special warnings and precautions for use)

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cream

A smooth white to off-white cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of sore and rough skin, based on traditional use only.

4.2 Posology and method of administration

For cutaneous use only

Wash hands before and after use.

Adults, the elderly and children over 6 years:

Apply liberally to affected area 4 times a day as required.

Not recommended for use in children under 6 years of age (See section 4.4. Special warnings and precautions for use)

4.3    Contraindications

Hypersensitivity to the active ingredient or to plants of the Asteraceae (Compositae) family or to any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose

The use in children under 6 years of age is not recommended because there is no experience available.

Avoid contact with eyes and mucous membranes.

If signs of skin infection are observed, a doctor or a qualified healthcare practitioner should be consulted.

This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

This product contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

None reported

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed

4.7 Effects on ability to drive and use machines

Studies on the effects on the ability to drive or operate machines have not been performed.

Undesirable effects

Skin sensitisation. The frequency is not known.

4.9 Overdose

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on genotoxicity, carcinogenicity and reproductive toxicity have not been performed.

Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified Water White soft paraffin

Polawax (Cetostearyl Alcohol, Polyoxyl 20 stearate)

Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216

Fragrance (Compo Cos: benzyl benzoate;propanol -oxybis; benzoate, 2,4-dihydro-3,6-dimethyl-, methyl; oils, oakmoss-resinoid)

Honey

6.2 Incompatibilities

None known.

Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C. Store in the original container

6.5 Nature and contents of container

Epoxy phenolic lacquered aluminium tube. Polyethylene cap. 30 g and 50 g.

6.6 Special precautions for disposal

There are no special instructions.

7 MARKETING AUTHORISATION HOLDER

A Nelson & Co Limited 5-9 Endeavour Way Wimbledon London SW19 8UH

Trading style: Nelsons Homoeopathy Boots Pharmaceuticals

8    MARKETING AUTHORISATION NUMBER(S)

THR 01175/0401

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/04/2013

10    DATE OF REVISION OF THE TEXT

24/04/2013