Cetalkonium Chloride: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 3, 2024🚩 Report this page

Cetalkonium Chloride

Active ingredient

Sold as BONJELA

GB MHRA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 2

Overview

Cetalkonium Chloride is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	May 3, 2024

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised May 3, 2024[1]

For the relief of pain, discomfort and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight minor mouth infection and aid healing of sore spots and ulcers due to dentures and orthodontic devices.

How to take

Sources & citations

[1]MHRA (UK) · PL000630122 · revised May 3, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 3, 2024[1]

The list of the following adverse effects relates to those experienced with topical oral salicylates at OTC doses, in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Adverse events which have been associated with salicylates are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness. System Organ Class Frequency Adverse Event Respiratory, Thoracic and Mediastinal Disorders Not known Bronchospasm, and asthma1. Immune System Disorders Not known Hypersensitivity 1Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised May 3, 2024[1]

Label warnings:
Do not exceed the stated dose. Consult your doctor or dentist before use if you are in the first or second trimester of pregnancy or when symptoms persist for more than seven days. Keep out of the reach of children. 83 mg of ethanol (alcohol) in each dose The amount in each dose of this medicine is equivalent to less than 2 ml beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects. It may cause burning sensation on damaged skin. This medicine contains less than 1 mmol sodium (23 mg) in each dose, that is to say essentially ‘sodium-free’.
This product contains salicylate and should not be used with Acetylsalicylic Acid (Aspirin) or other salicylates except under the direction of a doctor.

This is not medical advice. Consult a qualified healthcare professional.