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.



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


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).


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



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


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 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.


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.


References Cited

References Reviewed