Boots Sore Mouth Gel

Sore Mouth Gel or Boots Mouth Ulcer Gel

Oromucosal Gel

For the rapid relief of pain caused by minor recurrent aphthous mouth ulcers.

For topical application to the mouth and gums.

Adults and children

A small quantity of gel to be applied to the sore area with a clean finger every three hours as necessary.

Babies

Not suitable.

Patients hypersensitive to any of the ingredients.

Keep all medicines out of the reach of children.

If symptoms persist for more than seven days consult your doctor or dentist.

Not suitable for treatment of teething in children.

No clinically significant drug interactions known.

The safety of this product during pregnancy and lactation has not been established but is not considered to constitute a hazard.

No adverse effects known.

Hypersensitivity reactions due to lidocaine have been reported rarely and to cetylpyridinium chloride occasionally.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Overdosage with this product is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.

Lidocaine is a local anaesthetic of the amide type. Cetylpyridinium chloride is a cationic antiseptic.

Lidocaine is rapidly absorbed from mucous membranes. The plasma elimination half life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

Not applicable.

Refined sugar

Cetomacrogol 1000

Hypromellose

Alcohol 96%

Eucalyptol

Levomenthol synthetic or natural

Star anise oil

Purified water

None stated.

36 months.

Store below 25°C.

A collapsible aluminium tube, internally lacquered with a polyamide/polyimide lacquer system with a membrane seal fitted with a wadless polythene cap or polypropylene cap.

Pack size: 15 gm.

None stated.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0150

11 August 2018