1. Name Of The Medicinal Product
Boots Oral Antiseptic
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Mouthwash
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of mouth and throat infections.
For use after dental surgery and for daily oral hygiene.
4.2 Posology And Method Of Administration
For adults and children over six years, thoroughly rinse the mouth or gargle with at least 15ml (1 tablespoonful) 2 or 3 times a day.
Do not swallow.
Do not dilute. Product is ready for use.
4.3 Contraindications
Hypersensitivity to any of the ingredients, especially cetyl pyridinium chloride.
4.4 Special Warnings And Precautions For Use
Prolonged use of this preparation could lead to hypersensitivity to cetyl pyridinium.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions known.
4.6 Pregnancy And Lactation
The use of this preparation in pregnancy and lactation has not been studied but is unlikely to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are anticipated.
4.8 Undesirable Effects
Adverse effects are unlikely unless there is sensitivity to the ingredients, especially cetyl pyridinium which may cause nausea or vomiting.
4.9 Overdose
If accidentally swallowed in large quantities, signs of toxicity will include those associated with alcohol, sorbitol, menthol and cetyl pyridinium ingestion, including euphoria, slurred speech, nausea, vomiting, flatulence, diarrhoea and abdominal pain. Treatment includes stomach aspiration and lavage, supportive therapy should include keeping the patient warm. In children, overdosage could lead to hypoglycaemia, correct with dextrose.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Cetyl pyridinium chloride is a cationic disinfectant with gram, positive and negative activity which has been found to be of value in mouthwashes for treating superficial infections of the mouth and throat.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in the other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cetomacrogol 1000 croda
Saccharin 550
Alcohol 96%
Sorbitol solution non cryst
Levomenthol natural or synthetic
Peppermint oil
Methyl salicylate
Sodium bicarbonate
Quinoline yellow 14031 anst
Blue 12401 anst
Purified water
6.2 Incompatibilities
None
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
White flint glass bottle with roll on pilfer proof aluminium cap with a PVDC faced expanded polyethylene liner or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: unfitted polypropylene cap with a tamper evident band.
A PET bottle with a polypropylene cap with expanded polyethylene liner.
Pack sizes: 30ml, 50ml, 75ml, 100ml, 150ml, 200ml, 210ml, 250ml, 300ml, 500ml.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0277
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first grant: 18 November 1982
Date of last renewal: 18 November 1992
10. Date Of Revision Of The Text
August 1997
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