SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nelsons Bums Cream Savlon First Aid for Burns

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g cream contains:

30 mg tincture of Nettle Whole Plant (Urtica urens L.) (1:10), equivalent to 3 mg Nettle Whole Plant Extraction solvent: Ethanol 33% v/v

30 mg tincture of Calendula Flowers (Calendula officinalis L.) (1:10), equivalent to 3 mg Calendula Flowers Extraction solvent: Ethanol 33% v/v

24 mg tincture of St. John's Wort Herb (Hypericum perforatum L.) (1:10), equivalent to 2.4 mg St John's Wort Herb Extraction solvent: Ethanol 33% v/v

6 mg tincture of Echinacea Whole Plant (Echinacea angustifolia DC.) (1:10), equivalent to 0.6 mg Echinacea Whole Plant Extraction solvent: Ethanol 85% v/v

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

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of minor bums and scalds, based on traditionally 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 the cream to cover the affected area. Cover with a dry dressing and bandage lightly if necessary.

Durations of use:

Do not use for more than one week.

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

The use is not recommended in children under 12 years of age (See section 4.4. Special warnings and precautions for use.)

4.3 Contraindications

Hypersensitivity to any of the active ingredients 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 cream should not be swallowed.

Since no data on the safe use in children are available, the use in children under 12 years of age in not recommended.

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

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

Discontinue use, if the product causes the affected area of your skin to become more red, irritated or dry.

Avoid contact with the eyes and mucous membranes.

There is a risk of possible allergic reactions in sensitive individuals.

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

Contains Methyl parahydroxybenzoate and Propyl parahydroxybenzoate. May cause allergic reactions (possible delayed).

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

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

Studies on the effect on fertility have not been performed.

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Skin sensitization and hypersensitivity skin reactions may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

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

No reports of overdose.

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 reproductive toxicity, genotoxicity or carcinogenicity have not been performed.

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

For Hypericum perforatum - Studies on acute toxicity and repeated dose toxicity did not show signs of toxic effects.

The weak positive results of an ethanolic extract in the AMES-test (Salmonella typhimurium TA 98 and TA 100, with and without metabolic activation) could be assigned to quercetin and are irrelevant to human safety. No signs of mutagenicity could be detected in further in-vitro and in-vivo test systems.

Tests on reproductive toxicity revealed equivocal results.

Tests on the carcinogenic potential have not been performed

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified water White soft paraffin

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 with polypropylene/polyethylene cap 25 g and 30 g

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 Homeopathy

8    MARKETING AUTHORISATION NUMBER(S)

THR 01175/0399

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/04/2013

10 DATE OF REVISION OF THE TEXT

18/05/2016