ARNICA - ARNICA MONTANA
Semisolid dosage forms

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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 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.
• For arnica products using dosage forms other than the semisolids forms listed below, refer to the "Arnica" monograph.

Date

August 5, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)	Preparation(s)
Arnica montana	Arnica tincture1	Arnica montana	Flower	Dried
Arnica montana	Oil of Arnica2	Arnica montana	Flower	Dried

References: Proper name: USDA 2019, McGuffin et al. 2000; Common names: USDA 2019, McGuffin et al. 2000; Source material: Bradley 2006; Wichtl 2004; Cech 2000.

¹Arnica tincture must be prepared with diluted alcohol with an extract ratio of 1:5 or 1:10 (Bradley 2006; Mills and Bone 2005; Fenner 1918; Remington and Woods 1918).

²Oil of Arnica must be prepared with a 1:5 ratio of arnica flower in vegetable fixed oil (Bradley 2006; Wichtl 2004; Blumenthal et al. 2000; Cech 2000).

Route of Administration

Topical

Dosage Form(s)

The only acceptable dosage forms are the following topical semisolid dosage forms: creams, gels, lotions, ointments, pastes and salves.

Use(s) or Purpose(s)

(Traditionally) used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (such as sprains, bruises and/or joint pain) (Bradley 2006; Wichtl 2004; Williamson 2003; Blumenthal et al. 2000).

Note

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

Dose(s)

Subpopulation(s)

Children 2-11 years, Adolescents 12-17 years and Adults 18 years and older

Quantity(ies)

Arnica Tincture

Method of preparation: Tincture

Semisolid dosage forms containing 5 - 25% of Arnica tincture (Bradley 2006; Wichtl 2004; Williamson 2003; Blumenthal et al. 2000).

Oil of Arnica

Method of preparation: Oil, Medicated from dried plant

Semisolid dosage forms containing 1 - 15% of oil of Arnica (Bradley 2006; Wichtl 2004; Blumenthal et al. 2000; Cech 2000).

Direction(s) for use

All products

• Apply thinly and evenly to affected area up to 3 to 4 times per day (Pray 2006).
• Rub and/or massage into skin until the preparation disappears.
• For external use only.
• Avoid contact with the eyes and mucous membranes.
• Do not apply to wounds or damaged skin (Brinker 2010; Bradley 2006; Pray 2006; Cech 2000).
• Do not bandage (Pray 2006).
• Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn (Pray 2006).
• Do not apply on or near the nipple if you are breastfeeding (Brinker 2010; Mills and Bone 2005).

Products for Children 2-11 years

Application should be supervised by an adult (Bove 2001).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner 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)

Stop use if hypersensitivity/allergy occurs (Brinker 2010; Bradley 2006; Cech 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

No statement required.

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.
• he medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

• 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. 2nd edition. New York (NY): McGraw-Hill Publishing, Incorporated; 2001.
• Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association; 2006.
• Brinker F. Herbal Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications. [Internet]. [Accessed 2019 June 21]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions
• Cech R. Making Plant Medicine. Williams (OR): Horizon Herbs; 2000.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
• Pray WS. Non-Prescription Product Therapeutics. 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
• USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Online Database]. Arnica montana L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 June 21]. Available from:
• https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
• Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
• Williamson EM, Evans FJ, Wren RC. Potter's Herbal Cyclopaedia: The Authoritative Reference Work on Plants with a Known Medicinal Use. Saffron Walden (GB): The C.W. Daniel Company Limited; 2003.

References Reviewed

• 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.
• Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• British Pharmacopoeia 2011. Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2010.
• ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
• European Pharmacopoeia, 7.1 edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2011.
• Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Cincinnati (OH): John K. Scudder; 1922. [Internet]. Reprinted and abridged by Southwest School of Botanical Medicine; 2001. [Accessed 2011 February 2]. Available from: http://www.swsbm.com/FelterMM/Felters_Materia_Medica.pdf
• Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
• Fenner B. A Complete Formulary and Hand-book of Valuable Information for Pharmacists, Manufacturers of Chemical and Pharmaceutical Preparations, Physicians and Students of Pharmacy and Medicine. 6th edition. Westfield (NJ): B. Fenner, Publisher and Proprietor; 1888. [Internet]. Scanned by Southwest School of Botanical Medicine; 2001. [Accessed 2011 January 28]. Available from: http://www.swsbm.com/Fenners/Complete%20Formulary-3b.pdf
• Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
• Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
• The Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16]. Available from: http://www.medicinescomplete.com/mc/merck/current/monographs.htm
• Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
• Pizzorno JE, Murray MT, editors. 2006. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier.
• Remington JP, Woods HC, editors. The Dispensatory of the United States of America, 20th edition, 1918. [Internet]. Scanned by Southwest School of Botanical Medicine as - Abridged; botanicals only; 2008. [Accessed 2011 January 28]. Available from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
• Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists: With reference to Commission E Monographs of the Federal Department of Health in Germany. Includes 100 Commission E monographs and 15 ESCOP Monographs. Stuttgart (DE): Medpharm Scientific Publishers; 1997.
• Sweetman SC, editor. Martindale: The Complete Drug Reference. [Online]. London (GB): Pharmaceutical Press; 2011. [Arnica: Last modified 2010 November 27; Accessed 2011 February 1]. Available from: http://www.medicinescomplete.com