CRESCENT PHARMA CETRIMIDE ANTISEPTIC 0.5% W/W CREAM
Active substance(s): CETRIMIDE
NAME OF THE MEDICINAL PRODUCT
Crescent Pharma Cetrimide Antiseptic 0.5% w/w Cream
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.
Smooth opaque white cream
An antiseptic cream for chapped hands, minor skin abrasions, minor cuts and
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.
Hypersensitivity to cetrimide or to any of the excipients listed in section 6.1.
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
This medicine may cause allergic reactions (possibly delayed) as it contains E214,
E216 and E218.
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
No special precautions.
Effects on ability to drive and use machines
No or negligible influence.
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:
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).
D08A J04 – Antiseptics & Disinfectants Quaternary Ammonium Compounds
Contains Cetrimide which is a topical disinfectant.
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.
List of excipients
Phenonip [containing Phenoxyethanol, Methyl parahydroxybenzoate (E218),
Ethyl parahydroxybenzoate (E214), Butyl parahydroxybenzoate, Iso butyl 4hydroxybenzoate, Propyl parahydroxybenzoate (E216)]
Special precautions for storage
Nature and contents of container
15g, 30g, 45g, 50g and 60g lacquered aluminium tubes with HDPE cap.
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.
MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 & 4
Quidhampton Business Units
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT