CompoAtlas

ONRAL

Natural health product licensed in Canada

Licence holder
Syka Pharma inc.
NPN or DIN-HM
80128140
Status
Active licence
Licence date
21 November 2023
Revision date
14 January 2026
Form
Rince-bouche
Route of administration
Oromucosale
Application type
Officinale

Oral dose analysis does not apply without an established exclusively oral route.

Composition

Medicinal ingredient and sourcePer dosage unit, according to the source
Acide 4-aminobenzoïque, ester d'éthyle

Source : Benzocaine

5 %

Non-medicinal ingredients

Glycérol, Acide citrique, Poly(sorbate) 80, Sorbate de potassium, Saveur d'orange, PEG-400, Sorbitol, Eau purifiée, Saveur, Gomme de xanthane

PopulationAgeQuantity per servingFrequency
Adultesminimum: 19 years1minimum: 1 Tous les jours ; maximum: 4 Tous les jours
Enfants et Adolescentsminimum: 6 years ; maximum: 18 years1minimum: 1 Tous les jours ; maximum: 4 Tous les jours

Uses authorised in Canada

Text supplied in English because no French text is available.

For the temporary relief of occasional minor irritation or injury of the mouth. For the temporary relief of occasional minor oral irritation/oral pain/sore mouth. For the temporary relief of pain associated with canker sores/aphthous stomatitis. For the temporary relief of pain associated with cold sores/fever blisters/oral herpes.

A use authorised in Canada is not an authorised health claim in the European Union. See the health claims register.

Warnings in Canada

No French warning text available in the imported data.

Warnings are available in English on the official record.

Source

Official Health Canada record, licence 80128140

Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks, retrieved 27 October 2026.

Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)

Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)

The formula sold in Europe under the same name may differ. This information does not replace advice from a doctor or pharmacist.

List in the official revision dated (register: Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks).

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