Arnica

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

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Date: April 11, 2008

Proper name(s): Arnica montanaL. (Asteraceae) (USDA 1995)

Common name(s): Arnica, European arnica (McGuffin et al. 2000; USDA 1995)

Source material(s): Flower (Bradley 2006; Mills and Bone 2005; ESCOP 2003)

Route(s) of administration: Topical

Dosage form(s): Those suited to the allowable route(s) of administration.

Use(s) or Purpose(s): Statement(s) to the effect of:

Traditionally used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain) (Bradley 2006; ESCOP 2003; Grieve 1971 [1931]).

Dose(s):

Notes:

• Applicants are not required to disclose a quantity of crude equivalent (QCE) for arnica preparations.
• Extraction ratios are required on the Product Licence Application and product label for tinctures and ointments containing tinctures.

Infusion: 2 g of arnica flower (Bradley 2006)
Directions for use: Pour 100 ml of boiling water over flower and infuse (Bradley 2006). Let cool and apply to affected area(s) as needed.

Decoction: 2 g of arnica flower (ESCOP 2003)
Directions for use: Place flower in 100 ml of water and bring to a boil and simmer. Let cool and apply to affected area(s) as needed.

Fluidextract: 1:1 extraction ratio (ESCOP 2003)
Directions for use: For each millilitre of fluidextract, dilute with 3-10 ml of water (ESCOP 2003). Apply to affected area(s) as needed.

Tincture: 1:5 to 1:10 extraction ratio (Bradley 2006; Mills and Bone 2005)
Directions for use: For each millilitre of tincture, dilute with 3-10 ml of water (Bradley 2006; Mills and Bone 2005). Apply to affected area(s) as needed.

Arnica oil: Arnica flower extract (tincture, fluidextract):fatty oil (1:5) (Bradley 2006; Blumenthal et al. 2000)
Directions for use: Apply to affected area(s) as needed.

Ointment:

• 1-15% arnica oil (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000). See above for the acceptable arnica oil preparation.
• 5-25% tincture or fluidextract (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Blumenthal 2000).See above for acceptable tincture and fluidextract preparations.
  Directions for use: Apply to affected area(s) as needed.

For tinctures and ointments, see Appendix 1 for examples of appropriate dosage preparations and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration 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):

• Do not apply to broken skin (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Brinker 2001).
• Do not take internally (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Brinker 2001).
• Do not apply near or on the nipple if you are breastfeeding (Brinker 2008; Mills and Bone 2005).
• Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Brinker 2001).

Known adverse reaction(s):  Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Brinker 2001).

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
• The medicinal ingredient may comply with the specifications outlined in the Arnica Flower Monographs published in the European or British Pharmacopoeias.

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 2. Bournemouth (UK): British Herbal Medicine Association; 2006.

Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2008. [Accessed 2008-04-11]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html

Brinker F. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications; 2001.

ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.

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

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

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

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill
Livingstone; 2005.

USDA 1995: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN).  Arnica montanaL.  National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-04-11]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Appendix 1: Examples of appropriate dosage preparations and directions for use

Tincture:

• 1:10 extraction ratio (Bradley 2006)
• 1:5 extraction ratio (Mills and Bone 2005)

Directions for use:

• For each millilitre of tincture, dilute with 3-10 ml of water (Bradley 2006). Apply to affected area(s) as needed.
• For each millilitre of tincture, dilute with 5 ml of water (Mills and Bone 2005). Apply to affected area(s) as needed.

Ointment:

• 1-15% arnica oil (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000)
• 10-25% tincture (Bradley 2006; Mills and Bone 2005)
• 5-25% tincture or fluidextract (ESCOP 2003)
• 20-25% tincture (Blumenthal et al. 2000)

Directions for use: Apply to affected area(s) as needed.