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Drugs and Health Products

ALOE - ALOE VERA - Topical

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)
Aloe Vera
  • Aloe
  • Aloe vera
  • Barbados aloe
  • Curaçao aloe
  • True aloe
  • West Indian aloe
  • Aloe Vera Leaf gel

    References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000; Source material: Barnes et al. 2007, Williamson 2003.

    Route of administration

    Topical

    Dosage form(s)

    Acceptable dosage form for any age category listed in this monograph and specified route of administration are indicated in in the Compendium of Monographs Guidance Document.

    Use(s) or Purpose(s)

    • Used in Herbal Medicine to help relieve minor burns including sunburn (Barnes et al. 2007; Williamson 2003).
    • Used in Herbal Medicine to assist healing of minor wounds such as cuts and burns, and minor skin irritations (Barnes et al. 2007; Boon and Smith 2004; Williamson 2003; WHO 1999; Fulton 1990).

    Dose(s)

    Subpopulation(s)

    Children 2 to 11 years, adolescents 12 to 17 years and adults 18 years and older (McIntyre 2005; Bove 2001).

    Quantity(ies)

    Method of preparation: Fresh

    10 - 100 % leaf gel (WHO 1999)

    Direction(s) for use

    Apply to affected area(s) as needed.

    Duration(s) of use

    No statement is required.

    Risk information

    Caution(s) and warning(s)

    Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

    Contraindication(s)

    No statement required.

    Known adverse reaction(s)

    Stop use if hypersensitivity/allergy occurs (Brinker 2018; EMEA 2006).

    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

    • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press.
    • Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc
    • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing Incorporated.
    • Fulton JE. 1990. The stimulation of post dermabrasion wound healing with stabilized Aloe vera gel-polyethylene oxide dressing. Journal of Dermatologic Surgery and Oncology 16(5):460-467.
    • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
    • McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited.
    • USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Aloe vera (L.) Burm. f. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2018 June 1]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
    • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CHE): World Health Organization.
    • Williamson EM. 2003. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited.

    References reviewed

    • Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [Reprint of 1922 original].
    • Gallagher J, Gray M. 2003. Is aloe vera effective for healing chronic wounds? Journal of Wound, Ostomy and Continence Nursing 30(2):68-71.
    • Gerard J. 1975. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications.
    • HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, Stimulating Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2018 October 8]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquetpharm/laxstimu-eng.php
    • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
    • MacKay D, Miller AL. 2003. Nutritional support for wound healing. Alternative Medicine Review 8(4):359-377.
    • Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. 2007. The efficacy of aloe vera used for burn wound healing: a systematic review. Burns 33(6):713-718.
    • Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (UK): Thorsons Publishers Ltd.
    • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
    • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
    • Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers.
    • Vogler BK, Ernst E. 1999. Aloe vera: a systematic review of its clinical effectiveness. British Journal of General Practice 49(447):823-828.
    • Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited.