BOOTS ANTISEPTIC CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Antiseptic Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients                           ­%w/w

2,4– Dichlorobenzyl alcohol HSE             0.5%

Cetrimide EP                             ­0.5%

Allantoin BPC’ 34 BPC                    0­.2%

3 PHARMACEUTICAL FORM

Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For abrasions, minor burns and scalds, small areas of sunburn, dry chapped skin, nappy rash, insect bites, spots and pimples.

4.2 Posology and method of administration

Adults, Children and Elderly:

Apply the cream gently to the affected area two or three times a day.

For topical application.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Prolonged and repeated applications are inadvisable as hypersensitivity may occur.

If symptoms persist, consult your doctor.

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

No clinically significant interactions known.

4.6 Fertility, pregnancy and lactation

The safety of antiseptic cream during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Hypersensitivity reactions may occasionally occur in certain individuals following repeated application.

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

Where excessive application has been made to the skin, excess cream should be removed and the area washed with soap and water. Otherwise no further treatment is necessary.

In case of ingestion, the product may cause burns and irritation in the mouth and oesophagus. If any treatment is required at all, milk should be given to drink, otherwise symptomatic/sup­portive therapy should be given.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dichlorobenzyl alcohol has antiseptic properties. Cetrimide is a quarternary ammonium antiseptic which has bactericidal activity against both grampositive and gram negative organisms. Allantoin is claimed to stimulate tissue formation and hasten wound healing.

5.2 Pharmacokinetic properties

Not available.

5.3 Preclinical 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

Hydroxyethyl Cellulose

Cetostearyl Alcohol

Ceresin

Light Liquid Paraffin

Cetomacrogol

Dimethicone 20

Polyethylene Glycol 300

Perfume Compound AG 8053 CPL

Sodium Citrate Acid Granular

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Internally lacquered collapsible aluminium tube having a membrane seal and cap, in a cardboard carton.

Pack sizes: 15, 20, 25, 30, 35, 40, 50, 60, 75, 80, 100, 120g.

Laminate tube with polypropylene cap in a cardboard carton.

Pack sizes: 15, 20, 25, 30, 35, 40, 50, 60, 75, 80, 100, 120g.

Laminate tube with polypropylene cap and polythene/aluminium membrane seal in a cardboard carton.

Pack sizes: 15, 20, 25, 30, 35, 40, 50, 60, 75, 80, 100, 120g.

6.6 Special precautions for disposal

Not applicable