SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Weleda Calendula Cuts and Grazes Skin Salve.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1g of ointment contains 0.2ml of tincture from Calendula Herb (equivalent to 0.094g Calendula officinalis L. Herb).

Extraction solvent: Ethanol 90% v/v

1 g of ointment contains 324 mg of Lanolin (Wool Fat) (See section 4.4 ‘Special Warnings and Precautions for Use’)

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Cutaneous ointment

Smooth, soft, cream to pale yellow ointment.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for minor wounds, cuts and grazes, 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: Clean the affected area and apply to the affected area directly or on a dry dressing two to three times daily.

The use is not recommended in children under 6 years of age (See section 4.4 ‘Special Warnings and Precautions for Use’)

If the symptoms worsen or persist after 1 week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Calendula officinalis or to plants of the Asteraceaae (Compositae) family or to any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose

If the symptoms worsen or persist after 1 week, a doctor or a qualified healthcare practitioner should be consulted.

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

Avoid contact with eyes and mucous membranes.

Discontinue use if redness, irritation or dry skin occurs.

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

Contains lanolin (Wool Fat). May cause local skin reactions (eg 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 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 performed.

4.7    Effects on ability to drive and use machines

Not relevant.

4.8    Undesirable effects

Skin sensitization 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.

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 reproductive toxicity, genotoxicity or carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Wool Fat [Anhydrous Lanolin]

Sunflower Oil Olive Oil Yellow Beeswax Wool Alcohols

6.2 Incompatibilities

Not applicable

6.3 Shelf life

4 years

6.4 Special precautions for storage

Do not store above 25°C. Store in original package.

6.5 Nature and contents of container

6g and 25g collapsible aluminium tubes, internally lacquered, with plastic screw cap closure.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7    MARKETING AUTHORISATION HOLDER

Weleda (UK) Ltd Heanor Road Ilkeston

Derbyshire DE7 8DR, UK

8    MARKETING AUTHORISATION NUMBER(S)

THR 00298/0280

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29/04/2013

10 DATE OF REVISION OF THE TEXT

29/04/2013