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BOOTS ANTISPETIC CREAM

Active substance: DICHLOROBENZYL ALCOHOL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Boots Antiseptic Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
2,4-Dichlorobenzyl alcohol HSE
Cetrimide EP
Allantoin BPC’ 34 BPC

3

%w/w
0.5%
0.5%
0.2%

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 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

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:
Last Renewal:

10

7 November 1984
15 June 1995

DATE OF REVISION OF THE TEXT
14/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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