HEAL-ALL - PRUNELLA VULGARIS - Buccal and Oromucosal

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 299 KB)

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

April 28, 2023

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
Proper name(s)	Common name(s)	Source material(s)	Part(s)	Preparation(s)
Prunella vulgaris	Common selfheal Heal-all Prunella Self-heal Woundwort Xiakucao	Prunella vulgaris	Leaf Shoot Shoot and leaf	Dry

References: Proper name: USDA 2019; Common names: USDA 2019, McGuffin et al. 2000, Meyer 1993, Lust 1987; Source information: Bartram 1998, Hoffmann 1996.

Route(s) of administration

Buccal
Oromuccosal

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

The acceptable dosage forms when used according to the requirements indicated in this monograph to allow for direct contact between the affected tissue and the medicinal ingredient are as follows: Loose; Powder.

Use(s) or Purpose(s)

Traditionally used in Herbal Medicine to help relieve sore throats (Hoffman 1996; Felter and Lloyd 1983; Grieve 1971).
Traditionally used in Herbal Medicine to help relieve mild irritations of the mucous membranes of the mouth (Hoffmann 1996; Grieve 1971; Wren 1907; Meyrick 1790).

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Herbal Medicine to help relieve sore throats and mild irritations of the mucous membranes of the mouth (Hoffmann 1996; Felter and Lloyd 1983; Grieve 1971; Wren 1907; Meyrick 1790).

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

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, powdered

32 grams of dried shoots and/or leaves (Grieve 1971; Wren 1907).

Note: Dried or powdered shoots and/or leaves should be prepared as an infusion (see direction for use).

Direction(s) for use

Pour 475 ml (1 pint) of boiling water over 32 g (1 ounce) of dried/powdered shoots/shoots and leaves/leaves, infuse for 10 minutes and strain (Grieve 1971; Wren 1907).
Rinse and/or gargle as needed.

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)

No statement required.

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

Bartram T. 1998. Bartram's Encyclopedia of Herbal Medicine. New York (NY): Marlowe and Company.

Chevallier A. 1996. The Encyclopedia of Medicinal Plants. London (UK): Dorling Kindersley Limited.

Culpeper N. 1995. Complete Herbal. Ware (UK): Wordsworth Editions Limited; [Reprint of 1653 original].

Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; [Reprint of 1898 original].

Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].

Hoffmann D. 1996. The Complete Illustrated Holistic Herbal. Boston (MA): Element Books Ltd.

Lust J. 1987. The Herb Book. New York (NY): Bantam Books Incorporated, published by arrangement with Benedict Lust Publications.

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

Meyer JE. 1993. The Herbalist. Glenwood (IL): Meyerbooks.

Meyrick W. 1790. The New Family Herbal; or, Domestic Physician: enumerating, with accurate descriptions, all the known vegetables which are any way remarkable for medical efficacy; with an account of their virtues in the several diseases incident to the human frame. Birmingham (UK): Knott and Lloyd.

USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Prunella vulgaris L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2019 July 10]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx

Williamson EM. 2003. Potter's Herbal Cyclopaedia. Saffron Walden (UK): C.W. Daniel Company Limited.

Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and Clark.

References reviewed

Bensky D and Gamble A. 1993. Chinese Herbal Medicine Materia Medica. Revised edition. Seattle (WA): Eastland Press, Incorporated.

Duke JA, Bogenschutz-Godwin MJ, du Cellier J, Duke PK. 2002. Handbook of Medicinal Herbs, 2nd edition. Boca Raton (FL): CRC Press.

Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, Kasper DI, Hauser SL and Longo DL, 1998. editors. Harrison's Principles of Internal Medicine, 14th edition. Toronto (ON): McGraw-Hill Health Professions Division.

Fetrow CW, Avila JR. 2004. Professional's Handbook of Complementary and Alternative Medicines, 3rd edition. Philadelphia (PA): Lippincott Williams and Wilkins.

Gerard J. 1975. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications.

Hoffmann D. 2003. Medical Herbalism. Rochester (VT): Healing Arts Press.

McGuffin M, Hobbs C, Upton R, Goldberg A. 1997. editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.

Sherman JA. 1993. The Complete Botanical Prescriber, 3rd edition. Corvallis (OR): self-published.

Shou-zhong Y, translator. 2004. The Divine Farmer's Materia Medica - A translation of the Shen Nong Ben Cao Jing. Boulder (CO): Blue Poppy Press.

Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.

Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited.

Wiseman N and Ye F. 1999. A Practical Dictionary of Chinese Medicine. 2nd edition. Brookline (MA): Paradigm Publications.

Yeung H. 1998. Handbook of Chinese Herbal Formulas. Rosemeade (CA): Institute of Chinese Medicine.