SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nelsons Natural Care Strains Cream Nelsons Strains Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of cream contains:

9.0% v/w tincture of Common Rue herb (Ruta graveolens L) (1:10)

Extraction solvent: Ethanol 3.0 %v/w

Also contains cetostearyl alcohol, propyl parahydroxybenzoate (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 relief of muscular aches and sprains, based on traditional use only.

4.2 Posology and method of administration

For cutaneous use only

Adults, the elderly and children over 12 years:

Wash hands before and after use.

Apply liberally and massage gently into the affected area up to three times a day as required.

Duration of use:

If symptoms worsen or persist for more than two weeks, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or to plants of the Asteracaea (Compositae) family or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or persist after two weeks, a doctor or qualified healthcare practitioner should be consulted.

Not recommended for children under 12 yaesr of age as data rae not sufficient and medical advice should be sought.

Discontinue use if redness, irritation or dry skin occurs.

Avoid contact with the eyes and mucous membranes.

During treatment, intense UV-exposure of the respective skin areas should be avoided

Contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).

Contains cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis)

If articular pain accompanied by swelling of the joint, redness or fever are present, a doctor should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

The safety of the product 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

Not applicable

4.8    Undesirable effects

None reported.

If adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No reported case

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

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified Water White soft paraffin

Polawax GP200 (Cetostearyl alcohol, PEG-20 stearate)

Methyl parahydroxybenzoate E218

Honey

Propyl parahydroxybenzoate E216

6.2    Incompatibilities

None known

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5    Nature and contents    of container

Epoxy phenolic lacquered aluminium tube. Polyethylene cap. 25 g and 30 g.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

A Nelson & Co Limitted

5-9 Endeavour Way

Wimbledon

London

SW19 8UH

Trading style: Nelsons Homoeopathy

8    MARKETING AUTHORISATION NUMBER(S)

THR 01175/0407

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/04/2013

10    DATE OF REVISION OF THE TEXT

25/04/2013