Boots Alternatives Arnica Bruise Relief

1. Name Of The Medicinal Product

Arnica Cream

Nelsons Natural Care Bruise Cream

Boots Alternatives Arnica Bruise Relief

Savlon Natural First Aid for Bruises

* Only one trade name used on each product

2. Qualitative And Quantitative Composition

Arnica montana tincture 1/10 HSE 9.0% v/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

A topical herbal remedy traditionally used in the symptomatic treatment of bruises.

4.2 Posology And Method Of Administration

By external application. Apply gently to bruised areas.

The dosage is the same for adults, children and the elderly.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not apply to broken skin.

Discontinue use if skin rash or contact dermatitis appears.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not known.

4.6 Pregnancy And Lactation

As with many other medicaments, use during this period is at the physician's discretion.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

May cause hypersensitivity reactions and may cause dermatitis when applied to skin of sensitised individuals.

4.9 Overdose

If accidentally ingested, overdosage with Arnica may cause irritation of the gastro-intestinal tract, and possibly severe gastro-intestinal, nervous system and cardiovascular disturbances and collapse. Initial treatment should consist of gastric lavage; otherwise treatment should be symptomatic and supportive and may include the administration of demulcent.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable.

Used in accordance with homoeopathic tradition by reference to homoeopathic materia medica.

5.2 Pharmacokinetic Properties

Not applicable.

Used in accordance with homoeopathic tradition by reference to homoeopathic materia medica.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified Water

White soft paraffin

Cetearyl Alcohol, PEG-20 Stearate

Methyl parahydroxybenzoate

Honey

Propyl parahydroxybenzoate

6.2 Incompatibilities

Not known.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

Not applicable

Administrative Data

7. Marketing Authorisation Holder

A. Nelson & Co. Limited.

5 Endeavour Way

Wimbledon

London

SW19 9UH

Trading style: Nelsons Homoeopathy

Boots Alternatives

8. Marketing Authorisation Number(S)

PL 01175/5037R

9. Date Of First Authorisation/Renewal Of The Authorisation

Renewal of authorisation: 29/05/2001

10. Date Of Revision Of The Text

01/09/2003