Summary of Product Characteristics (SmPC) - Distilled Witch Hazel BPC
1 NAME OF THE MEDICINAL PRODUCT
Distilled Witch Hazel BPC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient % V/V Hamamelis water 100
3 PHARMACEUTICAL FORM
Topical Solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of the discomfort of bruises and sprains and minor skin irritations, roughness or soreness.
4.2 Posology and method of administration
Apply undiluted to the affected area and bandage. Keep the bandage moist with Witch Hazel.
For topical application to unbroken skin.
4.3 Contraindications
Hypersensitivity to hamamelis water.
4.4 Special warnings and precautions for use
For external use only on unbroken skin. Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 Pregnancy and lactation
The safety of Distilled Witch Hazel during pregnancy and lactation has not been established but is unlikely to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasional hypersensitivity reactions.
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 or search Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Accidental ingestion of Distilled Witch Hazel may give rise to gastrointestinal discomfort. Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Hamamelis water has cooling, astringent and haemostatic properties.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner.
An amber flint glass bottle with an aluminium roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: a polypropylene wadless tamper evident cap.
Pack size: 100ml, 200ml.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Crest Medical Limited
Unit 5 Farrell Industrial Estate
Howley Lane
Warrington
WA1 2PB
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 01021/0209
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/09/2006
10 DATE OF REVISION OF THE TEXT
10 DATE OF REVISION OF THE TEXT
23/06/2025