Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
ORALDENE is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE is also of value in the alleviation of halitosis and pre- and post-dental surgery.
Shake well before use. Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two to three times a day. Do not swallow the solution but spit out after use.
Not recommended.
For oromucosal use.
Acute alcoholic intoxication is extremely unlikely, however, it is theoretically possible that, if a massive dose were swallowed by a small child, alcoholic intoxication may occur due to the ethanol content.
There is no evidence to suggest that repeated, excessive administration of hexetidine would lead to hypersensitivity-type reactions.
No adverse effects have been reported in overdose other than those seen in normal use.
Hexetidine, at the strength present in ORALDENE, is unlikely to be toxic when used as directed.
Ingestion of sufficient quantities of hexetidine in alcoholic solution may lead to signs/symptoms of alcohol intoxication.
Treatment of overdose is symptomatic, but rarely required. In the event of accidental ingestion of the contents of a bottle by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should relate to treatment of alcoholic intoxication.
2 years.
6 months after first opening.
Do not store above 30°C. Keep the bottle in the outer carton in order to protect from light.
ORALDENE is presented in a clear 100 ml, 200 ml and 30 ml glass bottles, with white aluminium ROPP cap or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
