Buccal and Oromucosal

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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.



January 28, 2022

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
Source material(s) Part(s) Preparation(s)

Hamamelis virginiana

  • Hamamelis
  • Spotted alder
  • Winter bloom
  • Witchazel
  • Witch-hazel

Hamamelis virginiana

  • Bark
  • Leaf
  • Dry

    Hamamelis virginiana

    • Hamamelis water1
    • Witch hazel water1

    Hamamelis virginiana

    Twig dormant


    References: Proper name: USDA 2019; Common names: Bradley 2006, ESCOP 2003, McGuffin et al. 2000; Source information: Bradley 2006, ESCOP 2003.
    1Hamamelis/Witch hazel water: macerate 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, distill twigs to a ratio of 1:0.80-0.85 w/v (twigs:distillate). To the distillate, add 14-15% of ethanol (% of volume of distillate) (USP 32).
    2Dry = partially dried as per the USP preparation.

    Route(s) of Administration

    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; Liquid; Mouthwash; Solution.

    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 (Bradley 2006; ESCOP 2003; Felter 1983; Ellingwood 1983).


    Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



    Adults 18 years and older


    Hamamelis; Bark and/or Leaf

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

    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 Hamamelis water (Bradley 2006).

    Direction(s) for use

    All products

    Rinse and/or gargle as needed (Bradley 2006).


    Dilute with water (Bradley 2006).

    Duration(s) of Use

    No statement required.

    Risk Information

    Caution(s) and warning(s)

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


    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 (NHPR).


    References Cited

    Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.

    Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association. Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].

    ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.

    Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [Reprint of 1922 original].

    McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.

    USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Hamamelis virginiana L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 July 12]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx

    USP 32: United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

    References reviewed

    Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.

    Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association.

    Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated.

    BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1996.

    Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated.

    BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office.

    BPC 1934: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.

    BPC 1973: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.

    Brinker F. 2010. Updates and Additions for Herbal Contraindications and Drug Interactions plus Herbal Adjuncts with Medicines, 4th edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2019 July 12]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions

    Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.

    EMA 2008. European Medicines Agency. Committee on Herbal Medicinal Products. Draft. Community Herbal Monograph on Hamamelis virginiana L., FOLIUM et CORTEX DESTILLATUM and Hamamelis virginiana L., RAMUNCULUS DESTILLATIUM. [Accessed 2019 July 12]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-hamamelis-virginiana-l-folium-et-cortex-destillatum-hamamelis_en.pdf

    Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].

    Grieve M. 1971. A Modern Herbal, Volume 2. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].

    Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.

    McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press.

    McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited.

    Meyer JE. 1993. The Herbalist. Glenwood (IL): Meyerbooks.

    Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.

    Mills S. 1993. The Essential Book of Herbal Medicine. Toronto (ON): Arkana.

    Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (GB): Thorsons Publishers Ltd.

    Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.

    Ph. Eur. 2008: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

    Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.

    Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press.

    Williamson EM. 2003. Potter’s Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited.

    Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited.

    Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

    Zeylstra H. 1998. Hamamelis virginia. British Journal of Phytotherapy 5(1):23-28.