BLESSED THISTLE - CNICUS BENEDICTUS - Topical

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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 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 on the label.

Date

February 28, 2025

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
		Source material(s)	Part(s)	Preparation(s)
Cnicus benedictus	Blessed thistle Holy thistle	Cnicus benedictus	Herb top	Dry

References: Proper name: USDA 2024; Common names: Gardner and McGuffin 2013; Bradley 1992; Felter and Lloyd 1983; Source information: Williamson 2003; Bradley 1992.

Route of Administration

Topical

Dosage Form(s)

Acceptable dosage forms when used according to the requirements indicated in this monograph: Cream; Gel; Lotion; Liquid; Ointment; Paste; Salve; Solution; Topical liquid; Wipe.

Use(s) or Purpose(s)

Used in Herbal Medicine (as a vulnerary) to help heal minor wounds (such as cuts) (Williamson 2003; Bradley 1992).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Notes:

• On the PLA form, quantities can be expressed as percentage weight by weight (% w/w), percentage weight by volume (% w/v) or percentage volume by volume (% v/v), depending on the product formulation. On the product label, quantities can also be expressed in other equivalent concentration units (e.g., mg/mL).
• For wipes, the information in this section applies to the liquid with which wipes are saturated.

Methods of preparation: Dry, Powdered, Fluid Extract

1 - 10 % dried herb top in the finished product (Blumenthal et al. 2000; Bradley 1992).

Note: For fluid extracts, the extract ratio must be 1:1 and the solvent must be ethanol or a mix of ethanol and water.

Methods of preparation: Non-Standardized Liquid Extracts (Decoction, Decoction concentrate, Infusion, Infusion concentrate, Tincture)

1 - 100% dried herb top extract preparation in the finished product (Blumenthal et al. 2000; Bradley 1992).

Note: The extract ratio must be between 1:2 and 1:100. The formulation must be prepared in a way which is equivalent to a quantity of 10 to 100 milligrams crude dried herb tops for 1 gram of finished product. For example, for a tincture prepared with a 1:5 w/v ratio, the concentration of tincture in the finished product must be between 5 and 50% (10 – 100 mg crude dried herb tops * 5 w/v (dilution) = 50 – 500 mL liquid extract in 1 mL finished product = 5 – 50 % v/v extract preparation in the finished product).

Methods of preparation: Non-Standardized Dry Extracts (Extract dry)

0.5 - 10% dried herb top extract preparation in the finished product (Blumenthal et al. 2000; Bradley 1992).

Notes:

• The extract ratio must be between 2:1 and 20:1. The formulation must be prepared in a way which is equivalent to a quantity of 10 to 100 milligrams crude dried herb top for 1 gram of finished product. For example, for a dry extract prepared with a 2:1 w/w ratio, the concentration of extract in the finished product must be between 0.5 and 5% and the minimum quantity crude equivalent must be 20 mg dried herb tops (10 - 100 mg crude dried herb tops / 2 w/w (concentration) = 5 - 50 mg dry extract in 1 g finished product = 0.5 - 5% w/w extract preparation in the finished product).
• The minimum quantity of 0.5% still applies for more concentrated extracts (e.g. a product containing 0.5% of a dry extract contains 5 mg dry extract in 1 g finished product; 5 mg of a 20:1 w/w dry extract is equivalent to 100 mg crude dried herb tops).
• Solvents allowed for this method of preparation are ethanol and/or water.

Direction(s) for use

Apply to affected area(s), up to 3 times per day (Blumenthal et al. 2000; Bradley 1992).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

• For external use only.
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (Gardner and McGuffin 2013; Bradley 1992; Felter and Lloyd 1983).
• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or last (for) more than 7 days.
• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Contraindication(s)

Do not use on deep or puncture wounds, animal bites or serious burns.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Brinker 2010; Blumenthal et al. 2000).

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.

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.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

References Cited

• Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
• Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association; 1992.
• Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
• Gardner Z, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook. 2nd edition. Boca Ration (FL): Taylor and Francis Group; 2013.
• USDA 2024: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 July 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
• 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.

References Reviewed

• BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
• Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
• Dorland's 2003. Dorland's Illustrated Medical Dictionary. Online edition. Toronto (ON): WB Saunders Company, an Elsevier imprint; 2003. [Accessed 2024 July 11]. Available at: https://archive.org/details/dorlandsillustra0000unse_q9t6
• Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, Kasper DI, Hauser SL and Longo DL, editors. Harrison's Principles of Internal Medicine, 14th edition. Toronto (ON): McGraw-Hill Health Professions Division; 1998.
• Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
• Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003. Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
• Meyrick W. 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; 1790.
• Pugh MB, editor. Stedman's 27th Medical Dictionary. New York (NY): Lippincott Williams & Wilkins; 2000.
• Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.