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Boots Cold Sore Lotion

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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.

Special Warnings and Special Precautions for Use

4.4.


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.

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

19/02/2010