Summary of Product Characteristics (SmPC) - Boots Antiseptic cream
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%
Excipient(s) with known effect
Cetostearyl alcohol 10% w/w
Fragrance containing allergen (in Perfume Compound AG 8053 CPL)
For the full list of excipients, see section 6.1.
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.
Information about some of the ingredients
This medicine contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains fragrance with lilial which may cause allergic reactions.
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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 gram-positive 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
Hyetellose (Hydroxyethyl Cellulose) Cetostearyl Alcohol
Ceresin
Light Liquid Paraffin
Cetomacrogol 1000
Dimethicone 20
Polyethylene Glycol 300
Perfume Compound AG 8053 CPL (containing lilial) Sodium Citrate Granular
Anhydrous Citric 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
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/5138R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of First Authorisation: 7 November 1984 Last Renewal: 15 June 1995
10 DATE OF REVISION OF THE TEXT
08/07/2024