Summary of Product Characteristics (SmPC) - Weleda Hypercal Wound Salve
1 NAME OF THE MEDICINAL PRODUCT
Weleda HyperCal Wound Salve Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains:
0.10 ml of tincture from Calendula officinalis L., herba (Calendula herb) (equivalent to 50 mg of Calendula herb); Extraction solvent Ethanol 86 % w/w and
0.15 ml of tincture from Hypericum perforatum L., herba (St John’s Wort herb) (equivalent to 50 mg of St John’s Wort 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, buff to pale yellow ointment with a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of painful cuts and minor wounds. Based on traditional use only.
4.2 Posology and method of administration
For cutaneous use only.
Adults, the elderly and children over 12 years:
Wash hands before and after use.
Clean the affected area and apply directly or on a dry dressing two or 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 HyperCal Wound 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 12 years of age (See Section 4.4 Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to the active ingredients, 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 12 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.
During the treatment intense UV-exposure of the respective skin areas should be avoided.
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 been 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 the Yellow Card Scheme website at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
For Calendula officinalis – Available tests on genotoxicity (liquid extract with 60% ethanol) and on carcinogenicity (undefined extract) did not give any reason for concern.
For Hypericum perforatum – Studies on acute toxicity and repeated dose toxicity did not show signs of toxic effects.
The weak positive results of an ethanolic extract in the Ames-test (Salmonella typhimurium TA 98 and TA 100, with and without metabolic activation) could be assigned to quercetin and are irrelevant to human safety. No signs of mutagenicity could be detected in further in-vitro and in-vivo test systems. Tests on reproductive toxicity revealed equivocal results.
Tests on the carcinogenic potential have not been performed.
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 the original package.
6.5 Nature and contents of container
25g internally lacquered collapsible aluminium tubes with a membrane nozzle and latex seal with white HDPE pierce screw cap.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd
Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
THR 00298/0290
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/04/2013
10 DATE OF REVISION OF THE TEXT
02/03/2026