Hamamelis Water - 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, 2010Proper name(s)
Hamamelis virginiana L. (Hamamelidaceae) (USDA 1994)
Common name(s)
- Witch hazel water (McGuffin et al. 2000)
- Hamamelis water (Bradley 2006; ESCOP 2003)
Source material(s) and Route(s) of administration
Twig (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:
- (Traditionally) used in Herbal Medicine as an astringent (Bradley 2006; Felter 1983 [1922]) to help heal minor skin wounds, burns, bruises, irritations, and local inflammations (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Felter 1983 [1922]
- (Traditionally) used in Herbal Medicine) as an astringent (Bradley 2006; Ellingwood 1983[1919] to help relieve haemorrhoids (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Ellingwood 1983 [1919]
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):
- Witch hazel/Hamamelis water (Bradley 2006)
- 20-30% Witch hazel/Hamamelis water, in semi-solid preparations (Bradley 2006)
Directions for use:
- Apply (as a compress) to affected area(s) as needed (Bradley 2006).
- Optional: Dilute one part Witch hazel/Hamamelis water with 3 parts water (Bradley 2006).
Notes:
- 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.
- Semi-solid preparations include ointments, creams, gels and/or salves.
- 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 NNHPD 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 NNHPD Compendium of Monographs.
- The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 2 below.
- The medicinal ingredient Witch hazel/Hamamelis water must comply with the specifications outlined in the Witch hazel Monograph published in the US Pharmacopeia.
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. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 4 June 2008].
- 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].
- ESCO 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. Germplasm 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
TOPICAL:
Twig:
-
Undiluted and/or diluted Hamamelis water (Bradley 2006; Blumenthal et al. 2000).
Directions for use: Apply as a compress to affected area(s) as needed (Bradley 2006; Blumenthal et al. 2000). For a diluted preparation mix one part Hamamelis water with 3 parts water (Blumenthal et al. 2000).
-
20-30% Hamamelis water, in semi-solid preparations (Blumenthal et al. 2000).
Directions for use: Apply (as a compress) to affected area(s) as needed (Bradley 2006; Blumenthal et al. 2000).
Optional: For Hamamelis water: Dilute one part Hamamelis water with 3 parts water (Blumenthal et al. 2000).