Cetrimide 0.5% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetrimide

Available from:

A A H Pharmaceuticals Ltd

ATC code:

D08AJ04

INN (International Name):

Cetrimide

Dosage:

5mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100500

Patient Information leaflet

BLACK
4048/3
April 2019.
Use this medicine only on your skin.
Dalkeith Lab
BLACK
148.5x210mm
folded 26x74
4048/3
What is in this leaflet:
2. What you need to know before you use
this medicine
Warnings and precautions
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly 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. By reporting side effects you can help
provide more information on the safety of this medicine.
Marketing authorisation holder and manufacturer
_Continued, please turn over._
6. Contents of the pack and other
information
Tesco leaflet Cetrimlde PIL
Tesco Health Cetrimide Antiseptic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetrimide Antiseptic First Aid Cream
‘Morrisons’ Cetrimide Antiseptic First Aid Cream
Wilko Antiseptic Cream Cetrimide 0.5% w/w
Numark Antiseptic Cream Cetrimide 0.5% w/w
Superdrug Cetrimide Antiseptic 0.5% w/w Cream
Tesco Health Cetrimide Antiseptic 0.5% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 0.50 % w/w.
Excipients of known effect:
Cetostearyl alcohol, 0.5% w/w
Ethyl parahydroxybenzoate E214, 0.032% w/w
Propyl parahydroxybenxoate E216, 0.016% w/w
Methyl parahydroxybenzoate E218, 0.124% w/w.
For 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 and minor
cuts.
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 any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use this medicine only on your skin.
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis)
E214, E216 and E218 may cause allergic reactions (possibly delayed).
Prolonged and repeated applications of cetrimide are inadvisable as
hypersensitivity may occur.
Avoid contact with the eyes.
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 r