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Drugs and Health Products

ARNICA - SEMISOLID DOSAGE FORMS

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

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

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • 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

June 24, 2011

Proper name(s)

Arnica montana L. (Asteraceae) (USDA 2009; McGuffin et al. 2000)

Common name(s)

  • Arnica (USDA 2009; McGuffin et al. 2000)
  • European arnica (McGuffin et al. 2000)

Source material(s)

Flower (Bradley 2006; Wichtl 2004; Cech 2000)

Route(s) of administration

Topical

Dosage form(s)

The only acceptable dosage forms are semisolids (e.g. creams, gels, ointments, and salves).

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; Wichtl 2004; Williamson 2003; Blumenthal et al. 2000).

Note: Claims for traditional use must include the term "Herbal Medicine".

Dose(s)

Subpopulation(s)

For adults (≥ 19 years), adolescents (13-18 years), and children (2-12 years)

Quantity(ies):

  • Semisolid dosage forms containing 5-25% arnica tincture (Bradley 2006; Wichtl 2004; Williamson 2003; Blumenthal et al. 2000). An acceptable arnica tincture preparation is defined in the Arnica monograph.

  • Semisolid dosage forms containing 1-15% oil of arnica (Bradley 2006; Wichtl 2004; Blumenthal et al. 2000; Cech 2000). An acceptable oil of arnica preparation is defined in the Arnica monograph.

Directions for use:

Statement(s) to the effect of:

For 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).

For children (2-12 years):

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

Refer to Appendix 1 for examples of 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 use if you are allergic to plants of the Asteraceae/Compositae/Daisy family (Brinker 2010; Bradley 2006; Pray 2006).

Known adverse reaction(s)

Hypersensitivity/allergy has been known to occur; in which case, discontinue use (Brinker 2010; Bradley 2006; Cech 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.

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. Next link will take you to another Web site Final Updates and Additions for Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Internet]. [Last update 2010 July 13; Accessed 2011 June 23].
  • 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 2009: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web site Germplasm Resources Information Network (GRIN). [Online Database]. National Germplasm Resources Laboratory, Beltsville (MD). [Arnica montana L. Last updated 2009 December Accessed 2011 June 23].
  • 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. Next link will take you to another Web siteThe 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].
  • 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 Next link will take you to another Web site 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].
  • 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.
  • Next link will take you to another Web siteThe Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2010; Accessed 2011 June 16].
  • 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. Next link will take you to another Web siteThe 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].
  • 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, editor. Next link will take you to another Web site Martindale: The Complete Drug Reference. [Online]. London (GB): Pharmaceutical Press; 2011. [Arnica: Last modified 2010 November 27; Accessed 2011 February 1].

Appendix 1: Examples of dosage preparations and Directions for use

Ointment:
  • Preparations containing 1-15% arnica oil (Bradley 2006; Wichtl 2004; Blumenthal et al. 2000)
  • Preparations containing 10-25% tincture (Bradley 2006)
  • Preparations containing 20-25% tincture (Wichtl 2004; Blumenthal et al. 2000)

Directions for use Apply to affected area as needed.