ALOE - ALOE VERA - Topical
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(PDF Version - 36 K)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
December 29, 2023
Proper name(s), Common name(s), Source information
| Proper name(s) | Common name(s) | Source information | |
|---|---|---|---|
| Source material(s) | Part(s) | ||
| Aloe Vera |
|
Aloe Vera | Leaf gel |
References: Proper name: USDA 2023; Common names: USDA 2023, McGuffin et al. 2000; Source information: Barnes et al. 2007, Williamson 2003.
Route of administration
Topical
Dosage form(s)
Acceptable dosage forms for topical use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
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)
Ask 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
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.
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 2023: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2023 September 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
- 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.
- 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.