First Aid Antiseptic Spray
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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.
6.3
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