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Drugs and Health Products

Monograph: Hamamelis Water - Ophthalmic

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 Water (USDA 2008)

Proper Name(s)

Hamamelis virginiana L. (Hamamelidaceae) ( USDA 1994 )

Common Name(s)

Source Material

Twig ( ESCOP 2003 , Bradley 1992 )

Route Of Administration

Ophthalmic

Dosage Form(s)

Those pharmaceutical dosage forms suited to ophthalmic administration; liquids where the dose is measured in drops are acceptable.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Traditionally used in Herbal Medicine for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun  (EMEA 2008, Bradley 1992)

Dose(s)

Adults and adolescents 14 and over:

Preparation: Fresh

Dose(s): 2 Drops 3-6x/day, Hamamelis water, in each eye
Directions For Use: Dilute one part Witch hazel/Hamamelis water with 10 parts sterile water (EMEA 2008)


  • 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.
  • Witch hazel/Hamamelis water must be the unaltered product resulting from the preparation outlined in the Witch hazel Monograph published in the US Pharmacopoeia. The term "Witch hazel water" or "Hamamelis water" must appear on the label of products containing Witch hazel/Hamamelis water.

Duration of use

Use for a maximum of 4 days  (EMEA 2008)

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.
  • Discontinue use and consult a health care practitioner if you experience eye pain, changes in vision, continued redness, or irritation of the eye  (EMEA 2008)

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).
  • Products for ophthalmic uses must meet the specifications outlined in the current NHPD "Evidence for Quality of Finished Natural Health Products or Good Manufacturing Practices" Guidance Documents.
  • 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

OPHTHALMIC:

Twig:

Hamamelis water:

  • Distillate prepared from dried twigs (1:2; ethanol 14-15%) (EMEA 2008; USP 32)
  • Directions for use: Eye drops: Hamamelis distillate diluted (1:10), 2 drops/each eye, 3-6 times a day (EMEA 2008).