Crescent Pharma Cetrimide Antiseptic 0.5%w/w Cream

Country: United Kingdom

Language: English

Source: myHealthbox

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Active ingredient:

Cetrimide

Available from:

Crescent Pharma Limited

ATC code:

D08AJ04

INN (International Name):

Cetrimide

Dosage:

0.50 %w/w

Pharmaceutical form:

Cream

Administration route:

External use

Units in package:

15g, 30g, 45g, 50g and 60g

Prescription type:

GSL - General Sales List

Manufactured by:

Thorpe Laboratories Ltd

Therapeutic group:

Antiseptics & Disinfectants Quaternary Ammonium Compounds Contains Cetrimide which is a topical disinfectant.

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-04-09

Summary of Product characteristics

                                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
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