BOOTS ANTISEPTIC WOUND WASH, FIRST AID ANTISEPTIC SPRAY - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

First Aid Antiseptic Spray or Boots Antiseptic Wound Wash

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide 0.5 %w/v.

3 PHARMACEUTICAL FORM

Cutaneous spray, solution (Cutaneous spray)

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For cuts, grazes, insect bites, minor wounds, spots, minor burns and scalds.

4.2 Posology and method of administration

For topical application.

Adults, children and the elderly

Hold upright and spray from a distance of 2 to 4 inches on the affected area.

Spray the affected area two or three times a day.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Prolonged and repeated administration may lead to hypersensitivity.

Do not use if the skin is weeping or badly inflamed.

Avoid contact with the eyes.

For external use only.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

There are no clinically significant interactions.

4.6 Pregnancy and lactation

The safety of First Aid Antiseptic Spray during pregnancy and lactation has not been established but it is not considered to constitute a hazard during these periods.

4.7 Effects on ability to drive and use machines No adverse effects known.

4.8 Undesirable effects

Skin irritation may occasionally occur and hypersensitivity reactions may develop in certain individuals.

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

It is unlikely that systemic toxicity will result from the ingestion of First aid Antiseptic Spray, although it may give rise to gastrointestinal irritation.

Treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cetrimide is a quaternary ammonium disinfectant having bactericidal activity against both gram-positive and gram-negative organisms.

5.2

5.3

Pharmacokinetic properties None stated.

Preclinical safety data Not applicable.

6.1 List of excipients

Sodium citrate

Anhydrous citric acid

Di-Sodium edetate

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage None stated.

6.5 Nature and contents of container

Polythene bottle 100 ml with plastic spray pump of 50 microlitre dosage.