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Drugs and Health Products

Witch Hazel - Topical

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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

April 13, 2010

Proper name(s)

Hamamelis virginiana L. (Hamamelidaceae)(USDA 1994)

Common name(s)

  • Witch hazel (McGuffin et al. 2000)
  • Hamamelis (Bradley 2006; ESCOP 2003)

Source material(s) and Route(s) of administration

Bark (Bradley 2006; ESCOP 2003);  Leaf (Bradley 2006; ESCOP 2003)

Dosage form(s)

Those pharmaceutical dosage forms suited to topical administration.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Bark or leaf:
(Traditionally) used in Herbal Medicine as an astringent (Bradley 2006; Felter 1983[1922]) to help treat varicose veins (Mills and Bone 2000; Felter 1983[1922]; Grieve 1971[1931]).

Note: Claims for traditional use must include the term "Herbal Medicine".

Dose(s)

Subpopulation(s)

Adults, adolescents, and children ≥ 2 years (McIntyre 2005; Bove 2001; Schilcher 1997)
Quantity(ies)

Notes: Semi-solid preparations include ointments, creams, gels and/or salves.

Bark:

  • Preparations equivalent to 2-3 g dried bark (Blumenthal et al. 2000)
  • Semi-solid preparations containing 10% fluidextract or 10% decoction (Blumenthal et al. 2000)

Leaf:

  • Preparations equivalent to 5-10 g dried leaf (ESCOP 2003; Blumenthal et al. 2000)
  • Semi-solid preparations containing 10% fluidextract or 10% decoction (Blumenthal et al. 2000)
Directions for use

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

See Appendix 1 for examples of dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration(s) of use

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

Consult a health care practitioner if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

In rare cases, 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 NHPD Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 1 below.
  • The medicinal ingredient Witch hazel/Hamamelis water must comply with the specifications outlined in the Witch hazel Monograph published in the US Pharmacopeia.
Table 1: Monographs published in the British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) and the U.S. Pharmacopeia (USP)
Pharmacopoeia Monograph
BP
Ph. Eur.
Hamamelis Leaf Monograph
USP Witch hazel Monograph

References cited

  • 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.
  • 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.
  • BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office.
  • 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.
  • Brinker F. 2008. Next link will take you to another Web siteOnline Updates and Additions to 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].
  • EMEA 2008. European Medicines Agency. Committee on Herbal Medicinal Products. Draft. Next link will take you to another Web siteCommunity Herbal Monograph on Hamamelis virginiana L., FOLIUM et CORTEX DESTILLATUM and Hamamelis virginiana L., RAMUNCULUS DESTILLATIUM. [Accessed 30 March 2010].
  • 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].
  • 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.
  • 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.
  • 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 (D): Medpharm Scientific Publishers.
  • USDA 1994: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web siteGermplasm Resources Information Network (GRIN) [online database]. Hamamelis virginiana L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 4 June 2008].
  • 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

  • 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.
  • BPC 1934: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.
  • BPC 1973: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • 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.
  • 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.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Bark:

Decoction:
2-3 g dried bark (Blumenthal et al. 2000)

Directions for use: Place dried bark in 150 ml of water, bring to a boil and simmer for 10-15 minutes (Blumenthal et al. 2000); let cool and apply as a compress to affected areas as needed.

Semi-solid preparations (ointment, gel or salve):

  • 10% fluidextract (1:1, 45% alcohol) (Blumenthal et al. 2000)
  • 10% decoction (Blumenthal et al. 2000)

Directions for use: Apply (as a compress) to affected area(s) as needed (Blumenthal et al. 2000).

Leaf:

Decoction:
5-10 g dried leaf (ESCOP 2003; Blumenthal et al. 2000)

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

Semi-solid preparations (ointment, gel or salve):

  • 10% fluidextract (1:1, 45% alcohol) (Blumenthal et al. 2000)
  • 10% decoction (Blumenthal et al. 2000)

Directions for use: Apply (as a compress) to affected area(s) as needed (Blumenthal et al. 2000).