CALENDULA - CALENDULA OFFICINALIS - Topical

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 either term and/or statement may be selected on the label.

Date

January 30, 2026

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)
Calendula officinalis
  • Calendula
  • Garden-marigold
  • Marigold
  • Pot-marigold
  • Ruddles
  • Scotch-marigold
Calendula officinalis Flower Dry

References: Proper name: USDA 2024; Common names: Gardner and McGuffin 2013; Wiersema and León 1999; Source information: Bradley 2006; Mills and Bone 2005.

Route of Administration

Topical

Dosage Form(s)

The following dosage forms are acceptable when used according to the requirements indicated in this monograph: Cream; Gel; Liquid; Ointment; Salve; Solution; Spray.

Use(s) or Purpose(s)

  • (Traditionally) used in Herbal Medicine to help heal minor wounds (Bradley 2006; Hoffmann 2003; Ellingwood 1983; Felter and Lloyd 1983).
  • (Traditionally) used in Herbal Medicine to help relieve skin inflammations and irritations (Bradley 2006; Hoffmann 2003; ESCOP 2003; Blumenthal et al. 2000; Felter and Lloyd 1983).

Notes

  • The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Traditionally used in Herbal Medicine to help heal minor wounds and help relieve skin inflammations and irritations).
  • For multi-ingredient products:
    • To prevent the product from being represented as a “traditional medicine”, any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Calendula is traditionally used in Herbal Medicine to help heal minor wounds).
    • When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

Dose(s)

Subpopulation(s)

Children 2 to 11 years; Adolescents 12 to 17 years; Adults 18 years and older (McIntyre 2005; Schilcher 1997; Bove 1996).

Quantity(ies)

Liquid dosage forms: Liquid, Solution, Spray

Methods of preparation: Decoction, Decoction concentrate, Infusion, Infusion concentrate, Oil infused

90 - 100% of extract in the finished product (EMA 2018).

Methods of preparation: Tincture, Fluid extract

1 - 100% of extract in the finished product (EMA 2018; Saunders 2000).

Semi-solid dosage forms: Cream, Gel, Ointment, Salve

Methods of preparation: Dry, Powdered

2 - 20% of dried flower in semi-solid dosage forms (Bradley 2006, ESCOP 2003).

Methods of preparation: Tincture, Fluid extract

5 - 10% of extract in semi-solid dosage forms (Bradley 2006).

Note: For liquid and semi-solid dosage forms, the extracts are prepared as follows: Tincture (1:2 to 1:5); Fluid extract (1:1); Decoction or Infusion: 1-2 g of dried flower in 150-250 ml of water; Oil infused (1:10) (EMA 2018; ESCOP 2003; Saunders 2000).

Direction(s) for use

All products

Apply to affected area(s), as needed.

Tincture, Fluid extract (Optional)

  • Dilute 1 part of Calendula extract with 3 parts of freshly boiled, warm water and soak the compress (EMA 2018; Bradley 2006).
  • Change the compress several times per day (EMA 2018; Bradley 2006).

Infusion, Decoction (Optional)

  • Dilute 1 part of Calendula extract with 3 parts of freshly boiled, warm water and soak the compress (EMA 2018; Bradley 2006).
  • Change the compress several times per day (Bradley 2006; Saunders 2000).

Sprays

Avoid inhaling or exposing others to spray.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

  • Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
  • Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant.

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Brinker 2010; Mills and Bone 2005).

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.

Product Facts Table

References Cited

  • Blumenthal M, Goldberg A, Brinkmann 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. New Canaan (CT): Keats Publishing, Incorporated; 1996.
  • 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. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy, Volume 2. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original].
  • EMA 2018: European Union herbal monograph on Calendula officinalis L., flos [Accessed 2024 June 6]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-calendula-officinalis-l-flos-revision-1_en.pdf.
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • 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.
  • Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
  • McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Saunders PR. Herbal monograph: Calendula officinalis (L.), Asteraceae. The Canadian Journal of Herbalism 2000;21(1):14-17.
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • 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 May 31]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
  • Wiersema J, Léon B. World Economic Plants: A Standard Reference. Boco Raton (FL): CRC Press LLC; 1999.

References Reviewed

  • Barnes J, Anderson LA, Phillipson JD. Herbal Medicines, 3rd edition. London (UK): Pharmaceutical Press; 2007.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
  • Blumenthal M. The Complete German Commission E Monographs. Austin (TX): American Botanical Council; 1998.
  • Boon H, Smith MJ. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc; 2004.
  • Brayfield A, Cadart C, editors. Martindale: The Complete Drug Reference. London (GB): Pharmaceutical Press; 2024. [Accessed 2024 July 15]. Available from: https://www.medicinescomplete.com/#/browse/martindale

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