Boots Antiseptic Cream
SUMMARY OF PRODUCT 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.
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.
Effects on ability to drive and use machines
4.7
Not applicable
4.8 Undesirable effects
Hypersensitivity reactions may occasionally occur in certain individuals following repeated application.
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
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
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
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/5138R
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 7 November 1984
Last Renewal: 15 June 1995
DATE OF REVISION OF THE TEXT
14/07/2015