WITCH HAZEL - HAMAMELIS VIRGINIANA Buccal and Oromucosal

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Text in parentheses is additional optional information which can be included on the label at the applicant's discretion.
The solidus (/) indicates that either term and/or statement may be selected on the label.

Date

February 27, 2026

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s)	Common name(s)	Source information
Proper name(s)	Common name(s)	Source material(s)	Part(s)	Preparation(s)
Hamamelis virginiana	Hamamelis Spotted alder Winter bloom Witch hazel Witch-hazel	Hamamelis virginiana	Bark Leaf	Dry
Hamamelis virginiana	Hamamelis water¹ Witch hazel water¹	Hamamelis virginiana	Twig dormant	Dry²

References: Proper name: USDA 2025; Common names: Gardner and McGuffin 2013; Bradley 2006; ESCOP 2003; Source information: Bradley 2006; ESCOP 2003.
¹See dose section below for information on the method of preparation.
²Dry = partially dried as per the USP preparation.

Route(s) of administration

Buccal
Oromucosal

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

The following dosage forms are acceptable when used according to the requirements indicated in this monograph (allow for direct contact between the affected tissue and the medicinal ingredient): Gargle; Mouthwash.

Use(s) or Purpose(s)

(Traditionally) used in Herbal Medicine (as an astringent) to help relieve mild inflammations of the mucous membranes of the mouth and throat (EMA 2009; Bradley 2006; ESCOP 2003; Felter 1983; Ellingwood 1983).

Notes

For multi-ingredient products:
- To prevent the product from being represented as a "traditional medicine", any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Witch hazel is traditionally used in Herbal Medicine to help relieve mild inflammations of the mucous membranes of the mouth and throat).
- When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Hamamelis bark and/or leaf

Methods of preparation: Dry, Powdered, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)

2 - 10 grams of dried bark and/or leaf (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000).

Hamamelis water

Method of preparation: Distillation

100% of distillate (hamamelis water) in the finished product (Bradley 2006).

Note: Hamamelis/Witch hazel water is prepared by macerating in water recently cut and partially dried dormant twigs of Hamamelis virginiana in a ratio of 1:2 w/w (twigs:water) for 24 hours, and distilling twigs to a ratio of 1:0.80-0.85 w/v (twigs:distillate). To the distillate, 15% of ethanol (% of volume of finished product) is added. For example, 150 mL ethanol must be added to 850 mL distillate (USP-NF 2024).

Combination rule

No permitted combinations between the two medicinal ingredients listed in Table 1.

Direction(s) for use

All products

Use 1 tablespoon (15 mL)* as a mouthwash/gargle, up to 3 times a day (EMA 2009; Bradley 2006).

*Note: “1 tablespoon (15 mL)” can be replaced on the label with an equivalent dosage unit applicable to the product (e.g., “X capful”).

Tinctures

Dilute with water* (EMA 2009; Bradley 2006).

*Note: This statement can be removed from the label if the tincture is already diluted with water in the finished product. In addition, the statement can be revised on the label to specify the proportion of water to be mixed with the product prior to use.

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the NHPID.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References cited

Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association; 2006.
Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original].
EMA 2009: European Medicines Agency. Committee on Herbal Medicinal Products. Community herbal monograph on Hamamelis virginiana L., cortex. [Accessed 2026 February 3]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-hamamelis-virginiana-l-cortex_en.pdf
ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. 2^nd edition. Boca Ration (FL): Taylor and Francis Group; 2013.
USDA 2025: United States Department of Agriculture, Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System [Consulté le 21 janvier 2025]. Disponible à: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
USP-NF 2024: United States Pharmacopeia and the National Formulary. Rockville (MD): United States Pharmacopeial Convention, Inc.; 2024.

References reviewed

Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3^rd edition. London (GB): The Pharmaceutical Press; 2007.
Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association; 2002.
BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1996.
Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 2001.
BP 2008: British Pharmacopoeia Commission. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office; 2008.
BPC 1934: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press; 1934.
BPC 1973: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press; 1973.
Brayfield A, Cadart C, editors. Martindale: The Complete Drug Reference. London (GB): Pharmaceutical Press; 2024. [Accessed 2024 November 21]. Available from: https://www.medicinescomplete.com/#/browse/martindale
Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.
Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
Grieve M. A Modern Herbal, Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.
Mills S. The Essential Book of Herbal Medicine. Toronto (ON): Arkana; 1993.
Mills S. The Dictionary of Modern Herbalism. Wellingborough (GB): Thorsons Publishers Ltd; 1985.
Moerman DE. Native American Ethnobotany. Portland (OR): Timber Press; 1998.
Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers; 1997.
Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.
Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
Wren RC. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark; 1907.
Zeylstra H. Hamamelis virginia. British Journal of Phytotherapy 1998; 5(1):23-28.

Version History

Publication date	Update type	Summary of main updates (from Feb 2026)
2026-02-27	Minor updates	Introductory notes Common names Detailed information regarding the preparation of hamamelis water was moved from Table 1 footnot#1 to the Dose section Adjustment of the claim Removal of liquid and solution from the dosage forms Addition of notes in the Uses or purposes section Additional methods of preparation Adjustment of the quantity information to improve clarity Directions for use statements Risk statement wording Inclusion of a Product Facts Table example Reference section Inclusion of version history information
2022-01-28	Validation	-
2010-05-17	Initial release	-

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Date modified:: 2019-03-01