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Drugs and Health Products

Monograph: Witch Hazel - Buccal

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Notes: Text in parentheses is additional optional information which can be included on PLA and on product label at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-05-17

NHPID Name

Hamamelis virginiana (USDA 2008)

Proper Name(s)

Hamamelis virginiana L. (Hamamelidaceae) ( USDA 1994 )

Common Name(s)

Source Material


Route Of Administration

Buccal

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

(Traditionally) used in Herbal Medicine as an astringent to help relieve mild inflammations of the mucous membranes of the mouth  (ESCOP 2003, Bradley 1992, Ellingwood 1983[1919], Felter 1983[1922])

Dose(s)

Adults:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts Without Tincture

Dose(s): Leaf: 2 - 10 Grams , dried leaf
Directions For Use: Rinse mouth as needed (Bradley 1992)

Dose(s): Stem bark: 2 - 10 Grams , dried bark
Directions For Use: Rinse mouth as needed (Bradley 1992)

Preparation: Tincture

Dose(s): Leaf: 2 - 10 Grams , dried leaf
Directions For Use:

Dose(s): Stem bark: 2 - 10 Grams , dried bark (1:10)
Directions For Use:


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

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Hamamelis Leaf Monograph published in the British Pharmacopoeia or the European Pharmacopoeia or the Witch hazel monograph published in the United States Pharmacopoeia.

References cited

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • 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, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • 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. Community Herbal Monograph on Hamamelis virginiana L., folium et cortex destillatum and Hamamelis virginiana L., ramunculus destillatium. [Accessed 30 March 2010]. Available from: http://www.ema.europa.eu/pdfs/human/hmpc/hamamelidis_folium_et_cortex/11458408en.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. 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. Austin(TX): American Herbal Products Association.
  • McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • USDA 1994: 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 4 June 2008]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • 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 (UK): British Herbal Medical Association; 1996.
  • BPC 1934: The British Pharmaceutical Codex, 1934: An imperial dispensatory for the use of medical practitioners and pharmacists. London (UK): The Pharmaceutical Press; 1934.
  • BPC 1973: The British Pharmaceutical Codex. Londres (RU): The Pharmaceutical Press; 1973.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
  • Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
  • Mills S. The Essential Book of Herbal Medicine. Toronto (ON): Arkana; 1993.
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.
  • 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

BUCCAL:

Bark:

Infusion:

  • 2-3 g dried bark, several times per day [not to exceed 10 g, per day] (Blumenthal et al. 2000)
  • Directions for use: Pour 150 ml of boiling water on dried bark and steep for 10-15 minutes; use while still warm. Rinse mouth as needed (Blumenthal et al. 2000).

Decoction:

  • 2-10 g dried bark, per day (ESCOP 2003)
  • 2-3 g dried bark, several times per day [not to exceed 10 g, per day] (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; use while still warm. Rinse mouth as needed (Blumenthal et al. 2000).

Tincture:

  • 1:10 extraction ratio, 45% alcohol (Bradley 2006)
  • Directions for use: Dilute with water. Rinse mouth as needed (Bradley 2006).

Leaf:

Infusion:

  • 2-3 g dried leaf, several times per day [not to exceed 10 g, per day] (Blumenthal et al. 2000)
  • Directions for use: Pour 150 ml of boiling water on dried leaf and steep for 10-15 minutes; use while still warm. Rinse mouth as needed (Blumenthal et al. 2000).

Decoction:

  • 2-3 g dried leaf, several times per day [not to exceed 10 g, per day] (Bradley 2006)
  • 5-10 g dried leaf, per day (ESCOP 2003; Blumenthal et al. 2000)
  • Directions for use: Place dried leaf in 150-250 ml of water, bring to a boil and simmer 10-15 minutes; use while still warm. Rinse mouth as needed (Bradley 2006; Blumenthal et al. 2000).)

Twig:

  • Hamamelis water (undiluted) (Bradley 2006)
  • Directions for use: Rinse mouth as needed.