SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Boots First Aid Antiseptic Spray or Boots Antiseptic Wound Wash or Savlon First Aid Wash 0.5% w/v Cutaneous Spray, Solution.

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 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.

It is unlike ly that systemic toxicity will re suit from the ingestion of F irst 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 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate

Anhydrous citric acid Di-Sodium edetate Purified water

6.2 Incompatibilities

None stated.

Shelf life

36 months.

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.

6.6 Special precautions for disposal

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

7    MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West Nottingham NG2 3AA

Trading as: BCM

8    MARKETING AUTHORISATION NUMBER(S)

PL 0014/0507

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

11 April 1997

22/12/2014