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CRESCENT PHARMA CETRIMIDE ANTISEPTIC 0.5% W/W CREAM

Active substance(s): CETRIMIDE / CETRIMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Crescent Pharma Cetrimide Antiseptic 0.5% w/w Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 0.50 %w/w
Excipients with known effect:
Cetostearyl Alcohol 5.0 % w/w
Ethyl parahydroxybenzoate (E214) 0.032 %w/w
Propyl parahydroxybenzoate (E216) 0.016 %w/w
Methyl parahydroxybenzoate (E218) 0.124 %w/w
Butyl parahydroxybenzoate 0.032 %w/w
Isobutyl 4-hydroxybenzoate 0.016 %w/w
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Cream
Smooth opaque white cream

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
An antiseptic cream for chapped hands, minor skin abrasions, minor cuts and
nappy rash.

4.2

Posology and method of administration
For all ages.
For general use, clean surrounding skin and apply cetrimide cream directly or
on a piece of clean lint or gauze.

4.3

Contraindications
Hypersensitivity to cetrimide or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use
For external use only.
“Keep all medicines out of reach of children”.
Prolonged and repeated applications of cetrimide are inadvisable as
hypersensitivity may occur.
Avoid contact with the eyes.
This medicine may cause local skin reactions (e.g. contact dermatitis) as it contains
cetostearyl alcohol.
This medicine may cause allergic reactions (possibly delayed) as it contains E214,
E216 and E218.

4.5

Interaction with other medicinal products and other forms of interaction
None.

4.6

Fertility, pregnancy and lactation
No special precautions.

4.7

Effects on ability to drive and use machines
No or negligible influence.

4.8

Undesirable effects
Hypersensitivity reactions may occasionally occur in certain individuals and
present as localised contact dermatitis.
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
Overdosage with Cetrimide Cream is extremely unlikely. The ingestion of
very large quantities of cetrimide and other quaternary ammonium compounds
can cause nausea, vomiting, dyspnoea, cyanosis, CNS depression (sometimes
preceded by excitement and convulsions), hypotension and coma. The fatal
dose of quaternary ammonium compounds has been estimated to be 1 to 3
grams (equivalent to 200 – 600 grams of Cetrimide Cream 0.5% w/w).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
D08A J04 – Antiseptics & Disinfectants Quaternary Ammonium Compounds
Contains Cetrimide which is a topical disinfectant.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are
additional to those already included in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid Paraffin
Cetostearyl Alcohol
Phenonip [containing Phenoxyethanol, Methyl parahydroxybenzoate (E218),
Ethyl parahydroxybenzoate (E214), Butyl parahydroxybenzoate, Iso butyl 4hydroxybenzoate, Propyl parahydroxybenzoate (E216)]
Purified Water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life

48 months.
6.4

Special precautions for storage
None.

6.5

Nature and contents of container
15g, 30g, 45g, 50g and 60g lacquered aluminium tubes with HDPE cap.

6.6

Special precautions for disposal
Customers are advised that the product is for external use only and to keep all
medicines out of the reach of children.

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 & 4
Quidhampton Business Units
Polhampton Lane
Overton
Hants
RG25 3ED

8

MARKETING AUTHORISATION NUMBER(S)
PL 20416/0282

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/04/2015

10

DATE OF REVISION OF THE TEXT
09/04/2015

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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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