Monograph: Aloe - 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. It is a referenced document to be used as a labelling standard. Notes: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. Claims for traditional use must include the term "Herbal Medicine"
Date: 2018-07-31

NHPID name

Aloe vera ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Aloe Vera ( USDA 2018 )

Common name(s)

Source material

Leaf gel ( Barnes et al. 2007 , Williamson 2003 )

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:

Fresh

Dose(s):

10 - 100 Percent , leaf gel

Directions for use: Apply to affected area(s) 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/health care provider/health care professional/doctor/physician if symptoms persist or worsen. Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

References cited

References reviewed

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

Topical:

Leaf gel:

Preparations containing 10-70% leaf gel (WHO 1999)