Throat Lozenges Monograph

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Date

2018-12-07

Foreword

This monograph is intended to replace the existing Throat lozenges Monograph of January 13, 1995. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for throat lozenges products. The monograph identifies the permitted medicinal and non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be market authorized without the submission to Health Canada of additional evidence. It also may contain the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet the criteria outlined in this document can apply for market authorization outside of the monograph stream.

Applicants are reminded that throat lozenges products, like other non-prescription drugs or natural health products, are subject to the Food and Drug Regulations or the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD). This includes requirements related to labelling, manufacturing and product specifications. Additional information on labels, outside of those specified in the monograph, such as additional directions for use and/or non-therapeutic claims are acceptable as long as they meet the Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims, the Guidelines for Consumer Advertising of Health products for Nonprescription drugs, Natural Health Products, Vaccines and Medical Devices, and are not false, misleading or counterintuitive to the use of the product.

The development of this monograph is the result of a thorough review of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.

Notes

The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Text in parentheses is additional optional information which can be included on the Product Licence Application form and label at the applicant’s discretion.

Medicinal Ingredient(s)

Throat lozenges products are classified as natural health products (NHPs) if they contain only ingredients from Table 1, 2 and 3. Applicants applying for an NPN can access the appropriate forms and guidance at:https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html.

Throat lozenges products are classified as non-prescription drugs if they contain at least one ingredient from Table 4 and 5. Applicants applying for a DIN can access the appropriate forms and guidance at:https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

Table 1. NHP medicinal ingredients (analgesic/anaesthetic)
Proper name(s) Common name(s) Source material(s) Quantity per lozenge
Common name(s)

alpha-Hydroxytoluene

Benzyl alcohol

Benzyl alcohol

100 - 500 mg

4-Aminobenzoic acid, ethyl ester

Benzocaine

Para-aminobenzoic acid

2 - 15 mg

2-Hydroxybenzenemethanol

Salicyl alcohol

Salicyl alcohol

50 - 100 mg

  • (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

2 - 20 mg

  • (1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexan-1-ol
  • l-Menthol
  • l-Menthol
  • Menthol

l-Menthol

2 - 20 mg

Phenol

Phenol

Phenol

10 - 50 mg

Table 2: NHP medicinal ingredients (demulcent)
Proper name(s) Common name(s)
Source material(s)
Quantity per lozenge
Proper name(s) Common Name(s) Part(s)

Gelatin

  • Gelatin
  • Partially hydrolyzed collagen

N/A

Gelatin

N/A

≤100%

Pectin

Pectin

N/A

Pectin

N/A

≤100%

Ulmus rubra

  • Slippery elm
  • red elm

Ulmus rubra

N/A

Stem bark inner

10-15%

Table 3: NHP Complementary medicinal ingredient (safety only)1
Proper name(s) Common name(s)
Source material(s)
Quantity per lozenge
Proper name(s) Part(s)

Eucalyptus globulus

  • Eucalyptus essential oil
  • Eucalyptus globulus leaf essential oil

Eucalyptus globulus

Leaf

0.2-15 mg

Table 2 Footnotes

Table 3 Footnote 1

See permitted combinations.

Return to Table 3 footnote1 referrer

Table 4: Non-prescription drug medicinal ingredients (analgesic/anaesthetic)
Proper name(s) Common name(s)
Source material(s)
Quantity per lozenge
Common name(s)

4-n-Butoxy-beta-(1-piperidyl)propiophenone hydrochloride

Dyclonine hydrochloride

Dyclonine hydrochloride

1-3 mg

  • 4-Hexyl-1,3-benzenediol
  • 4-Hexylresorcinol

Hexylresorcinol

Hexylresorcinol

2-4 mg

Table 5: Non-prescription drug medicinal ingredients (antiseptic)
Proper name(s) Common name(s)
Source material(s)
Quantity per lozenge
Common name(s)

1-Hexadecylpyridinium chloride

Cetylpyridinium chloride(antiseptic)

Cetylpyridinium chloride

1-2 mg

  • 1,1'-(1,10-Decanediyl)bis-(4-amino-2-methylquinolinium chloride)
  • 1,1'-Decamethylenebis(4-aminoquinaldinium chloride)

Dequalinium chloride (antiseptic)

Dequalinium chloride

0.25 mg

  • Dodecyldimethyl(2-phenoxyethyl)ammonium bromide
  • N,N-Dimethyl-N-(2-phenoxyethyl)-1-dodecanaminium bromide

Domiphen bromide(antiseptic)

Domiphen bromide

1.5 mg

  • 4-Hexyl-1,3-benzenediol
  • 4-Hexylresorcinol

Hexylresorcinol (analgesic/anesthetic/antiseptic)

Hexylresorcinol

2-4 mg

Route of Administration

Oral

Dosage Form(s)

Lozenges

Use(s) or Purpose(s)

Self-Care Framework Category I Uses or Purposes:

For all products:

For products containing menthol, phenol, hexylresorcinol, benzocaine, dyclonine hydrochloride, benzyl alcohol, salicyl alcohol:

For products containing slippery elm bark powder, gelatin, or pectin:

For products containing menthol with a concentration of 1 - 20 mg:

For products containing menthol with a concentration of 5 - 20 mg:

For products containing hexylresorcinol, cetylpyridinium chloride, domiphen bromide, phenol, or dequalinium chloride:

Dose(s)

Subpopulation(s)

Children 6 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older

Quantity(ies)

See Tables 1, 2, 3, 4 and 5 above.

Permitted combinations:

The concentration of the individual ingredients must not exceed the maximum value permitted as single medicinal ingredients, as listed in Table 1, 2, 3, and 4 above.

Direction(s) for use

For products containing menthol, eucalyptus oil, gelatin or pectin:

For products containing phenol:

For products containing hexylresorcinol, benzyl alcohol, dyclonine hydrochloride, cetylpyridinium chloride, domiphen bromide, dequalinium or salicyl alcohol:

For products containing slippery elm bark powder:

For products containing benzocaine:

Duration(s) of Use

For products containing benzocaine:

Risk Information

Caution(s) and warning(s)

For all products:

For products including claim for the temporary relief of (minor) sore throat and/or temporary relief of pain of (minor) sore throat:

For products including claim for the temporary relief of coughs:

For products containing ingredients in Tables 4 or 5:

For products containing benzocaine:

Contraindication(s)

For products containing benzocaine:

Known adverse reaction(s)

For products containing benzocaine:

Non-medicinal ingredients

Ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and the current Cosmetic Ingredient Hotlist, when relevant.

Storage conditions

No statement required.

Specifications

This monograph describes those requirements that are specific to this class of non-prescription drugs and to natural health products (NHPs). Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph.

For products containing Table 1, 2 and 3 NHP medicinal ingredients only:

The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide. The medicinal ingredient must comply with the requirements outlined in the NHPID.

For products containing Table 4 and 5 non-prescription drug medicinal ingredients:

Requirements described in the Regulations to the Food and Drugs Act must be met.

DRUG FACTS TABLES (Format Optional for Self-Care Category I)

Drug Facts Table

Drug Facts Table

Drug Facts Table

Drug Facts Table

Drug Facts Table

References