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Drug information

Boots Cold Sore lotion

OTC
Read time: 1 mins
Last updated: 24 Nov 2015
...
 

Summary of product characteristics


1. Name of the medicinal product

Boots Dual Action Cold Sore Lotion or Boots Cold Sore Lotion.


2. Qualitative and quantitative composition

Active ingredient

 % w/v

Benzyl alcohol

Camphor

Levomenthol

Dichlorobenzyl alcohol

 2.0

0.1

0.2

0.25


3. Pharmaceutical form

Lotion


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. Contraindications

Hypersensitivity to any of the ingredients.


4.4. Special warnings and 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. Fertility, 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.


5.1. 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. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.


6.1. List of excipients

Propylene glycolIndustrial methylated spirits


6.2. Incompatibilities

Not applicable


6.3. Shelf life

36 months


6.4. Special precautions for storage

None


6.5. Nature and contents 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. Special precautions for disposal and other handling

None


7. Marketing authorisation holder

The Boots Company PLC1 Thane Road WestNottingham 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

9 October 2015

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 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and 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 Fertility, 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.

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The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

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Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).