Boots Cold Sore Lotion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Dual Action Cold Sore Lotion Boots Cold Sore Lotion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active ingredient |
% w/v |
|
Benzyl alcohol |
2.0 |
|
Camphor |
0.1 |
|
Levomenthol |
0.2 |
|
Dichlorobenzyl alcohol |
0.25 |
3. PHARMACEUTICAL FORM
Lotion
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the relief of cold sores.
4.2. Posology and Method of Administration
For topical application.
Adults and children:
Apply directly to the cold sore as soon as it first appears. Repeat frequently.
Elderly:
The normal adult dose is suitable in the elderly.
4.3. Contra-Indications
Hypersensitivity to any of the ingredients.
4.4. Special Warnings and Special Precautions for Use
For external use only.
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 drug interactions known.
4.6 Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.
4.7. Effects on Ability to Drive and Use Machines
No adverse effects known.
4.8. Undesirable Effects
Occasional hypersensitivity reactions and stinging.
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.
4.9
Overdose
In view of the small volume involved, this product should only present a hazard after overdosage by mouth in young children.
Symptoms of overdosage may include nausea, vomiting, confusion, ataxia, headache, dizziness, blurred vision, inebriation, hypoglycaemia and possible convulsions.
Treatment consists of gastric lavage if indicated and supportive therapy.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Camphor and menthol have mild local analgesic properties.
Benzyl alcohol has antimicrobial and weak local anaesthetic activity. Dichlorobenzyl alcohol has antiseptic properties.
5.2. Pharmacokinetic Properties
No data available.
5.3. Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Propylene glycol Industrial methylated spirits
6.2. Incompatibilities
Not applicable.
6.3. Shelf-Life
36 months.
6.4. Special Precautions for Storage
None.
6.5. Nature and Content of Container
Cylindrical white flint glass bottles with either thermoset plastic caps or tin plate cap, both fitted with tin plate faced Liner or aluminium-faced liner or aluminium/melinex-faced liner.
Pack sizes: 5ml, 10ml.
6.6. Instructions for Use, Handling and Disposal
None.
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8. MARKETING AUTHORISATION NUMBER(S)
PL 00014/0345
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 18 February 1986/25 February 1997
10 DATE OF REVISION OF THE TEXT
8th July 2015.