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BOOTS PHARMACEUTICALS BRUISE RELIEF ARNICA CREAM

Active substance(s): ARNICA MONTANA TINCTURE 1:10 / ARNICA MONTANA TINCTURE 1:10

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Bruise Relief Arnica Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains:
9.0 mg tincture of Arnica Whole Plant (Arnica montana L.) (1:10), equivalent to 0.9
mg Arnica Whole Plant
Extraction solvent: Ethanol 57% 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

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of bruises,
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:
Apply to affected area 4 times a day as required.
If symptoms worsen or persist after using the product for 2 weeks, a doctor or
qualified healthcare practitioner should be consulted

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
Avoid contact with eyes and mucous membranes. Not to be applied to broken or
irritated skin. Discontinue use if skin becomes red, dry or irritated.
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.

4.8

Undesirable effects
Hypersensitivity (contact dermatitis, itching skin rash) has been reported. 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
If accidentally ingested, due to the irritant effect of the product, symptoms of
intoxication may include gastro-intestinal and nervous system disturbances; dizziness,
diarrhoea, shivering and palpitations. Respiratory difficulties may occur at very high
doses. Treatment of the overdose: the stomach should be emptied by aspiration or
lavage if the patient has not already vomited. Demulcent drinks such as milk should
be given.

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 and carcinogenicity 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
Propyl parahydroxybenzoate E216
Honey

6.2

Incompatibilities
Not 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, 30 g and 50 g.

6.6

Special precautions for disposal
Not applicable

7

8

MARKETING AUTHORISATION HOLDER

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

MARKETING AUTHORISATION NUMBER(S)
THR 01175/0398

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/04/2013

10

DATE OF REVISION OF THE TEXT
12/12/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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