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Drugs and Health Products

Monograph: Calendula - Topical

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Date: 2008-01-25

NHPID Name

Calendula officinalis (USDA 2008)

Proper Name(s)

Calendula officinalis L. (Asteraceae) ( USDA 2008 )

Common Name(s)

Source Material

Flower ( Bradley 2006 , Mills and Bone 2005 )

Route 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:

Dose(s)

Adults, adolescents and children 2 and older:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 1 - 4 Grams , dried flower
Directions For Use: Apply to affected areas as needed

Preparation: Dry & Powder

Dose(s): 2 - 10 Percent , dried flower, in an ointment base
Directions For Use: Apply to affected areas as needed


See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are pregnant

Contraindication(s):
Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family  (Brinker 2007, ESCOP 2003)

Known Adverse Reaction(s):
Hypersensitivity/allergy is known to occur, in which case, discontinue use  (Brinker 2007, Mills and Bone 2005)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (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. 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. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2007. [Accessed 2007-11-21]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • 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].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • 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 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
  • Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
  • Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.

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

TOPICAL:

Ointment:

  • 2 - 5% (2 - 5 g dried flower per 100 g ointment) (Bradley 2006)
  • 10 - 12% (10 - 12 g dried flower per 100 g ointment) (Bradley 2006)
  • 2 - 10% (2 - 10 g dried flower per 100 g ointment) (ESCOP 2003)

Directions for use:

Apply to affected area as needed.

Infusion:

1 - 2 g dried flower (ESCOP 2003)

Directions for use:

Pour 150 ml of boiling water over dried flower and infuse (ESCOP 2003). Apply to affected area as needed.

Fluid extract:

2 - 4 g dried equivalent (1:1, 40% alcohol, 2-4 ml) (Saunders 2000)

Directions for use:

Add to 250 ml water (Saunders 2000). Apply to affected area as needed.