Summary of Product Characteristics (SmPC) - Weleda Calendula Cuts and Grazes spray
1 NAME OF THE MEDICINAL PRODUCT
Weleda Calendula Cuts & Grazes Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of spray contains 0.2g of Calendula officinalis herb (equivalent to 0.10g Calendula officinalis L. Herba).
Extraction solvent: Ethanol 90% v/v.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Spray, Solution.
Pale yellow to yellow green liquid .
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of minor wounds, cuts and grazes, based on traditional use only.
4.2 Posology and method of administration
For cutaneous use.
Wash hands before and after use.
Adults, the elderly and children over 6 years:
Directions: For application to the skin. Wash hands before and after use. Clean the affected area if required.
Spray one or two metered sprays on the affected area as required, up to three times a day and allow to dry. May also be sprayed onto a clean dressing and applied to the cut or graze.
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 Asteraceae (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.
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 been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed.
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.
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
Ethanol 43% w/w
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened
4 years:
After first opening:
6 months
6.4 Special precautions for storage
Do not store above 25°C. Store in original package
6.5 Nature and contents of container
20 ml amber glass bottle with composite spray atomiser and polypropylene overcap.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd
Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 00298/0292
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/03/2013
10 DATE OF REVISION OF THE TEXT
02/03/2026