NATURAL HEALTH PRODUCT

PROPOLIS
Buccal

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.

Date July 31, 2018

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

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

Source material(s)
Proper name(s) Common names(s)
Proper name(s) Part(s)
Propolis Bee propolis Apis mellifera Secretion
Feng jiao
Propolis
Propolis balsam
Propolis resin
Propolis wax
References: Proper name: Lotfy 2006, PPRC 2005; Common names: O’Neil et al. 2013, Lotfy 2006,
PPRC 2005, Salatino et al. 2005, Marcucci 1995; Source material: Ramos et al. 2007, Burdock 1998.

Route of administration

Buccal

Dosage form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of
Monographs Guidance Document.
Acceptable dosage forms for the age category listed in this monograph and specified route of
administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

(Traditionally) used in Herbal Medicine to help relieve sore throat and/or other mouth and throat
infections (Castalado and Capasso 2002; Mills and Bone 2000; Tilgner 1999).

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

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid
extract, Decoction, Infusion)

0.2 - 0.6 grams dried propolis, per day (PPRC 2005)

Direction(s) for use

No statement required.

Duration(s) of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician

for use beyond 1 month (Jasprica et al. 2007).

Risk information

Caution(s) and warning(s)

All products

Propolis - Buccal Page 2 of 7

 Consult a health care practitioner/health care provider/health care professional/doctor/
physician prior to use if you are allergic to bee products, poplar tree products, or balsam of
Peru (Brinker 2001; Marcucci 1995; Valsecchi and Cainelli 1984; Melli et al. 1983; Rudzki
and Gryzwa 1983).
Consult a health care practitioner/health care provider/health care professional/doctor/
physician if symptoms persist or worsen.

Buccal products, except those not swallowed (e.g. gargles, rinses)

Consult a health care practitioner/health care provider/health care professional/doctor/physician

prior to use if you are pregnant or breastfeeding.

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Scully 2006; PPRC 2005; Hsu et al. 2004; Teraki and
Shiohara 2001; Machácková 1988; Hausen et al. 1987; Valsecchi and Cainelli 1984; Melli et al.
1983; Rudzki and Grzywa 1983).

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.
The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic
Medical Publications.

Propolis - Buccal Page 3 of 7

Burdock GA. 1998. Review of the biological properties and toxicity of bee propolis (propolis).
Food and Chemical Toxicology 36:347-363.

Castalado S, Capasso F. 2002. Propolis, an old remedy used in modern medicine. Fitotherapia
73(S1):S1-S6.

Hausen BM, Wollenweber E, Senff H, Post B. 1987. Propolis allergy (II): the sensitizing
properties of 1,1-dimethylallyl caffeic acid ester. Contact Dermatitis 17:171-177.

Hsu CY, Chiang WC, Weng TI, Chen WJ, Yuan A. 2004. Laryngeal edema and anaphalactic
shock after topical propolis use for acute pharyngitis. American Journal of Emergency Medicine
22(5):432-433.

Jasprica I, Mornar A, Debeljak Z, Molcic-Bubalo A, Medic-Saric M, Mayer L, Romic Z, Bucan

K, Balog T, Sobocanec S, Sverko V. 2007. In vivo study of propolis supplementation effects on
antioxidative status and red blood cells. Journal of Ethnopharmacology 110:548-554.

Lotfy M. 2006. Review: Biological activity of bee propolis in health and disease. Asian Pacific
Journal of Cancer Prevention 7:22-31.

Machackova J. 1988. The incidence of allergy to propolis in 605 consecutive patients patch
tested in Prague. Contact Dermatitis 18:210-212.

Marcucci MC. 1995. Propolis: chemical composition, biological properties and therapeutic
activity. Apidologie 26:83-89.

Melli MC, Giorgini S, Sertoli A. 1983. Occupational dermatitis in a bee-keeper. Contact

Dermatitis 9(5):427-428.

Mills S and Bone K. 2000. Principles and Practice of Phytotherapy; Modern Herbal Medicine.
London (GB): Churchill Livingstone.

O’Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia
of Chemicals, Drugs, and Biologicals. 15th edition. Whitehouse Station (NJ): Merck & Co., Inc;
2013.

PPRC 2005: Pharmacopoeia of the People’s Republic of China, Volume 1, English edition 2005.
Beijing (CN): The State Pharmacopoeia Commission of the People’s Republic of China.

Ramos AFN, Miranda JL. 2007. Propolis: a review of its anti-inflammatory and healing actions.
J. Venom. Anim. Toxins incl. Trop. Dis. 13(4):697-710.

Rudzki E, Grzywa Z. 1983. Dermatitis from propolis. Contact Dermatitis 9(1):40-45.

Salatino A, Teixeira EW, Negri G, Message D. 2005. Review: Origin and chemical variation of
Brazilian propolis. Oxford University Press eCAM 2(1):33-38.

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Scully C. 2006. Propolis: A background (Letter). British Dental Journal 200(7):359-360.

Teraki Y, Shiohara T. 2001. Propolis-induced granulomatous contact dermatitis accompanied by

marked lymphadenopathy. British Journal of Dermatology 144:1277-1278.

Tilgner S. 1999. Herbal Medicine: From the Heart of the Earth. Creswell (OR): Wise Acres Press
Inc.

Valsecchi R, Cainelli T. 1984. Dermatitis from propolis. Contact Dermatitis 11(5):317.

References reviewed

Bankova V. 2005. Review: Recent trends and important developments in propolis research.
Oxford University Press eCAM 2(1):29-32.

Botushanov PI, Grigorov GI, Aleksandrov GA. 2001. A clinical study of a silicate toothpaste
with extract from propolis. Endodontology and Parodontology 43(1-2):28-30.

Cairo do Amaral R, Gomes RT, Rocha WMS, Abreu SLR, Santos VR. 2006. Periodontitis
treatment with Brazilian green propolis gel. Pharmacologyonline 3:336-341. [Accessed 2013
December 23]. Available from:
http://pharmacologyonline.silae.it/files/archives/2006/vol3/026.Santos.pdf

Coelho LG, Bastos EMAF, Resende CC, Paula e Silva CM, Sanches BSF, Castro FJ,
Moretzsohn LD, Vieira WLS, Trinidade OR. 2007. Brazilian green propolis on Helicobacter
pylori infection. A pilot clinical study. Helicobacter 12:572-574.

Crisan I, Zaharia CN, Popovici F, Jucu V, Belu O, Dascalu C, Mutiu A, Petrescu A. 1995.
Natural propolis extract NIVCRISOL in the treatment of acute and chronic rhinopharyngitis in
children. Romanian Journal of Virology 46(3-4):115-133.

El-Khatib AS, Agha AM, Mahran LG, Khayyal MT. 2002. Prophylactic effect of aqueous
propolis extract against acute experimental hepatotoxicity in vivo. Verlag der Zeitschrift fur
Naturforsch 57c:379-385.

Fuliang HU, Hepburn HR, Xuan H, Chen M, Daya S, Radloff SE. 2005. Effects of propolis on
blood glucose, blood lipid and free radicals in rats with diabetes mellitus. Pharmacological
Research 51:147-152.

Gabrys J, Konecki J, Krol W, Scheller S, Shani J. 1986. Free amino acids in bee hive product
(propolis) as identified and quantified by gas-liquid chromatography. Pharmacological Research
Communications 18(6):513-518.

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Gambelunghe C, Rossi R, Sommavilla M, Ferranti C, Rossi R, Ciculi C, Gizzi S, Micheletti A,
Rufini S. 2003. Effects of Chrysin on Urinary Testosterone Levels in Human Males. Journal of
Medicinal Food;6(4):387-390.

Gebara ECE, Pustiglioni AN, de Lima LAPA, Mayer MPA. 2003. Propolis extract as an
adjuvant to periodontal treatment. Oral Health and Preventative Dentistry 1(1):29-35.

Ghisalberti EL. 1979. Propolis: a review. Bee World 60:59-84.

Giusti F, Miglietta R, Pepe P, Seidenari S. 2004. Sensitization to propolis in 1255 children

undergoing patch testing. Contact Dermatitis 51:255-258.

Gregory SR, Piccolo N, Piccolo MT, Piccolo MS, Heggers JP. 2002. Comparison of Propolis
Skin Cream to Silver Sulfadiazine: A Naturopathic Alternative to Antibiotics in Treatment of
Minor Burns. The Journal of Alternative and Complementary Medicine 8(1):77-83.

Imhof M, Lipovac M, Kurz Ch, Barta J, Verhoeven HC, Huber JC. 2005. Propolis solution for
the treatment of chronic vaginitis. International Journal of Gynecology and Obstetrics
89:127132.

Khayyal MT, El-Ghazaly MA, El-Khatib AS, Hatem AM, de Vries PJF, El-Shafei S, Khattab
MM. 2003. A clinical pharmacological study of the potential beneficial effects of a propolis food
product as an adjuvant in asthmatic patients. Fundamental and Clinical Pharmacology 17:93-102.

Koo H, Cury JA, Rosalen PL, Ambrosano GMB, Ikegaki M, Park YK. 2002. Effect of a
mouthrinse containing selected propolis on 3-day dental plaque accumulation and polysaccharide
formation. Caries Research 36(6):445-448.

Krell R. 1996. Value-Added Products from Beekeeping [online] Agricultural Services Bulletin
No. 124. Rome (IT): Food and Agriculture Organisation of the United Nations, Agriculture and
Consumer Protection. [Accessed 2008 October 31]. Available from:
http://www.fao.org/docrep/w0076E/w0076E00.htm

Machackova J. 1988. The incidence of allergy to propolis in 605 consecutive patients patch
tested in Prague. Contact Dermatitis 18:210-212.

Magro-Filho O, de Carvalho AC. 1994. Topical effect of propolis in the repair of sulcoplasties
by the modified Kazanjian technique. Cytological and clinical evaluation. Journal of the Nihon
School of Dentistry 36(2):102-111.

Menniti-Ippolito F, Mazzanti G, Vitalone A, Firenzuoli F, Santuccio C. 2008. Surveillance of

suspected adverse reactions to natural health products: the case of propolis. Drug Safety 31(5)
419-423.

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Mirzoeva OK and Calder PC. 1996. The effect of propolis and its components on eicosanoid
production during the inflammatory response. Prostaglandins, Leukotrienes and Essential Fatty
Acids 55(6):441-449.

Murray MC, Worthington HV, Blinkhorn AS. 1997. A study to investigate the effect of a
propolis-containing mouthrinse on the inhibition of de novo plaque formation. Journal of
Clinical Periodontology 24:796-798.

Nakajima Y, Tsuruma K, Shinazawa M, Mishima S, Hara H. 2009. Comparison of bee products

based on assays of antioxidant capacities. BMC Complementary and Alternative Medicine
9(1):4.

NMCD 2008: Natural Medicines Comprehensive Database. Propolis [online]. Stockton (CA):
Therapeutic Research Faculty; 1995-2008. [Accessed 2008 October 15]. Available from:
http://www.naturaldatabase.com/(S(rmsj0i45yh1x1nv212frlvid))/nd/Search.aspx?cs=&s=ND&pt
=100&id=390&ds=

NMQS 2008: Natural Medicine Quality Standards: The Authority on Integrative Medicine.
Propolis. Cambridge (MA): Natural Standard Inc. [Accessed 2008 October 15]. Available from:
http://www.naturalstandard.com/index-
abstract.asp?createabstract=/monographs/herbssupplements/patient-propolis.asp

PasseportSanté.net 2006 : Propolis. [online]. Montréal (QC) : PasseportSanté.net, Totalmédia

Inc. [Accessed 2009 January 28]. Available from :
http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=propolis_ps

Santos VR, Pimenta FJGS, Aguiar MCF, do Carmo MAV, Naves MD, Mesquita RA. 2005.
Short Communication: Oral Candidiasis Treatment with Brazilian Ethanol Propolis Extract.
Phytotherapy Research 19:652-654.

Sforcin JM. 2007. Propolis and the immune system: a review. Journal of Ethnopharmacology
113:1-14.

Viuda-Martos M, Ruiz-Navajas Y, Fernández-López J, Pérez-Alvarez JA. 2008. Functional

properties of honey, propolis, and royal jelly. Journal of Food Science 73(9):R117-124.

Vynograd N, Vynograd I, Sosnowski Z. 2000. A comparative multi-centre study on the efficacy

of propolis, acyclovir and placebo in the treatment of genital herpes (HSV). Phytomedicine
7(1):1-6.

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