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Distilled Witch Hazel BPC (Boots Company plc)
Active Ingredient:
hamamelis
Company:
THE BOOTS COMPANY PLC
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This information is for use by healthcare professionals
Last updated on emc: 30 Aug 2023
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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 and other handling
Not applicable.
7. Marketing authorisation holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing authorisation number(s)
PL 00014/5645R
9. Date of first authorisation/renewal of the authorisation
| Date of First Authorisation: | 2 August 1983 |
| Date of Last Renewal: | 23 February 1996 |
10. Date of revision of the text
24th July 2023
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