Summary of medicine characteristics - WELEDA CALENDULA CUTS AND GRAZES SKIN SALVE
1 NAME OF THE MEDICINAL PRODUCT
Weleda Calendula Cuts and Grazes Skin Salve Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains:
0.20 ml of tincture from Calendula officinalis L., herba (Calendula herb)
(equivalent to 100 mg of Calendula herb);
Extraction solvent: Ethanol 86% w/w
Excipients with known effect:
1g of ointment contains 324 mg Wool Fat (Lanolin)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment.
A smooth, soft, cream to pale yellow ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the treatment of minor wounds, cuts and grazes. Based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Adults, the elderly and children over 6 years:
Wash hands before and after use.
Clean the affected area and apply to the affected area directly or on a dry dressing two to three times daily.
Duration of use
Do not use for more than one week.
If symptoms worsen, persist or do not improve after one week of use of Weleda Cuts & Grazes Skin Salve Ointment a qualified healthcare practitioner or health care professional eg a doctor or pharmacist should be consulted.
The use is not recommended in children under 6 years of age (See section 4.4 Special Warnings and Precautions for Use).
4.3 Contraindications
Hypersensitivity to Calendula officinalis, other species of the Asteraceae (Compositae) family or any of the other ingredients of the product listed in section 6.1.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Since no data on the safe use in children are available, the use in children under 6 years of age is not recommended.
If symptoms worsen, persist or do not improve after one week, a qualified healthcare practitioner or health care professional eg a doctor or pharmacist should be consulted.
If signs of skin infection are observed, a qualified healthcare practitioner or health care professional eg a doctor or pharmacist should be consulted.
Discontinue use if redness, irritation or dry skin occurs.
Avoid contact with the eyes or mucous membranes.
Contains Wool Fat (Lanolin). May cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
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 sensitisation has been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a qualified healthcare practitioner or health care professional eg a doctor or pharmacist 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 Yellow Card Scheme website
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseNo 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
5.2 Pharmacokinetic propertiesNot 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.
Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Herbal Preparation:
Ethanol
Purified Water
Ointment:
Wool Fat [Anhydrous Lanolin]
Refined Sunflower Oil
Virgin 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.