MEDICATED VAPOURS

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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

Date

April 29, 2019

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

Table 1. Proper name(s), Common name(s), Source material(s) - Medicinal ingredients
Proper name(s) Common name(s) Source ingredient(s) Source material(s)
Common name(s) Proper name(s) Part(s)
  • (1R,2S,5R)-rel-5-methyl-2-(1-methylethyl)-cyclohexanol
  • (1RS,2RS,5RS)-(±)-5-methyl-2-(1-methylethyl) cyclohexanol
  • dl-Menthol
  • dl-Menthol
  • Racemic Menthol
dl-menthol N/A N/A
  • (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexanol
  • (1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexan-1-ol
  • l-Menthol
  • l-menthol
  • Menthol
l-menthol N/A N/A
Eucalyptus globulus
  • Eucalyptus essential oil
  • Eucalyptus Globulus Leaf essential oil
N/A Eucalyptus globulus Leaf

References: NHPID 2019.

Table 2. Proper name(s), Common name(s), Source material(s) - Complementary ingredients
Proper name(s) Common name(s) Source ingredient(s)
Common name(s)
  • (1R,4R)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-one
  • d-Camphor
  • (+)-Camphor
  • Camphor
  • d-Camphor
  • Natural camphor
d-camphor
  • (1RS,4RS)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-one
  • dl-Camphor
  • (+-)-Camphor
  • dl-camphor
  • Racemic camphor
dl-camphor

References: NHPID 2019.

Route of Administration

Note

This monograph excludes vaping products.

Dosage Form(s)

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

Use(s) or Purpose(s)

Products containing dl-Menthol, l-Menthol and/or Eucalyptus essential oil

(Provides soothing vapours that) Help(s) to temporarily relieve mild nasal congestion and cough associated with the common cold (EMA 2012; Paul et al. 2010; Lis-Balchin 2006; Bove 2001; Gladstar 1999; Schilcher 1997; Morice et al. 1994; HC 1989).

Note

Camphor alone does not support the above claim. It must be combined with at least 1 of the 2 other medicinal ingredients listed in Table 1 (i.e. menthol and/or eucalyptus essential oil).

Dose(s)

Subpopulation(s)

Children 2 to 11 years, Adolescents 12 to 17 years and Adults 18 years and older.

Quantity(ies)

Table 3. Medicinal Ingredient Doses
Medicinal Ingredients Doses1,2
l-Menthol 1 - 16%
dl-Menthol 1 - 16%
Eucalyptus essential oil 1 - 25%

1The maximum concentrations are supported by the following reference: HC 2013.
2The use of the medicinal ingredients in children is supported by the following references: HC 2013;Paul et al. 2010; Bove 2001; Gladstar 1999; Schilcher 1997.

Table 4. Complementary ingredient Doses (safety only)
Complementary Ingredients Doses1,2
d-Camphor 1 - 11%
dl-Camphor 1 - 11%

1The maximum concentrations are supported by the following reference: HC 2013.
2The use of the medicinal ingredients in children is supported by the following references: HC 2013;Paul et al. 2010; Bove 2001; Gladstar 1999; Schilcher 1997.

Direction(s) for use

All products

For children and adolescents 2-12 years

The product should be handled/applied by adults only.

Products in liquid or semi-solid form (i.e. chest rubs)

Apply thinly and evenly to the chest, up to 3 times per day.

Products in patch forms or vaporizers

Do not use (on skin) for more than 8 hours.

Notes

Duration(s) of Use

All products

Risk Information

Caution(s) and warning(s)

All products

Topical products

Avoid exposure of applied area to the sun.

Contraindication(s)

All products

Known adverse reaction(s)

All products

Stop use if hypersensitivity/allergy, rash, burning discomfort, nausea, dizziness and/or headache occur.

Topical products containing menthol

Stop use and get medical help right away if you experience pain, swelling or blistering (HC 2017).

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

Specifications

References Cited

References Reviewed