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Drugs and Health Products

WITCH HAZEL - HAMAMELIS VIRGINIANA
Topical

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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.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant

Date

January 21, 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

    Dry2

    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 of Administration

    Topical

    Dosage Form(s)

    The following dosage forms are acceptable when used according to the requirements indicated in this monograph.

    • Semisolid dosage forms: Cream; Gel; Lotion; Ointment; Paste; Salve
    • Liquid dosage forms: Liquid; Solution
    • Loose; Powder

    Use(s) or Purpose(s)

    Hamamelis; Bark and/or Leaf

    (Traditionally) used in Herbal Medicine (as an astringent) to help treat varicose veins (Bradley 2006; Mills and Bone 2000; Felter 1983; Grieve 1971).

    Hamamelis water

    • (Traditionally) used in Herbal Medicine (as an astringent) to help heal minor skin wounds, burns, bruises, irritations, and local inflammations (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Felter 1983).
    • (Traditionally) used in Herbal Medicine (as an astringent) to help relieve haemorrhoids (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Ellingwood 1983).

    Note

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

    Dose(s)

    Subpopulation(s)

    Children 2-11 years, Adolescents 12-17 years and Adults 18 years and older (McIntyre 2005; Bove 2001; Schilcher 1997)

    Quantity(ies)

    Hamamelis; Bark and/or leaf

    Loose; Powder

    Methods of preparation: Dry, Powdered

    Bark
    2 - 3 grams of dried bark, per day (Blumenthal et al. 2000)

    Leaf
    5 - 10 grams of dried leaf, per day (ESCOP 2003; Blumenthal et al. 2000)

    Note: Dried/powdered bark or leaves should be prepared as a decoction (see direction for use).

    Cream; Gel; Lotion; Ointment; Paste; Salve

    Methods of preparation: Decoction, Fluid extract

    Bark

    10 % of extract* in a semi solid preparation (Blumenthal et al. 2000)

    *Equivalent to 2-3 g of dried bark

    Leaf

    10 % of extract* in a semi solid preparation (Blumenthal et al. 2000)

    *Equivalent to 5-10 g of dried bark


    Hamamelis water

    Liquid; Solution

    Method of preparation: Distillation

    30 - 100% of Hamamelis water (Bradley 2006)

    Cream; Gel; Lotion; Ointment; Paste; Salve

    Method of preparation: Distillation

    20 - 30% of Hamamelis water in a semi solid preparation (Bradley 2006)

    Direction(s) for use

    All products

    Apply to affected area(s) as needed (Bradley 2006).

    Dry/Powdered

    Bark

    Place dried bark in 250 ml of water, bring to a boil and simmer 10-15 minutes; let cool and apply as a compress to affected area(s), or rinse/wash affected areas(s) as needed (Blumenthal et al. 2000)

    Leaf

    Place dried leaf in 250 ml of water, bring to a boil and simmer 10-15 minutes; let cool and apply as a compress to affected area(s), or rinse/wash affected areas(s) as needed (Blumenthal et al. 2000)

    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.

    Contraindication(s)

    No statement required.

    Known adverse reaction(s)

    Some people may experience a (skin) rash (ESCOP 2003; Berardi et al. 2002; Mills and Bone 2000).

    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).

    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.

    References Cited

    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.

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

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

    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.

    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].

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

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

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

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

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

    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 11]. 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.

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

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

    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 11]. 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.

    Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].

    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 11]. 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].

    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. 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.

    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.

    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.