DRAPOLENE CREAM, BENZALKONIUM CHLORIDE 0.01% W/W ,
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
BENZALKONIUM CHLORIDE CETRIMONIUM BROMIDE
Available from:
Chefaro Ireland Limited
Dosage:
0.01/0.2 %w/w
Pharmaceutical form:
Cream
Authorization date:
2005-01-14
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Drapolene Cream
Benzalkonium chloride 0.01% w/w
Cetrimide 0.2% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DRAPOLENE Cream contains benzalkonium chloride 0.01% w/w (as benzalkonium chloride solution 0.02% w/w) and
Cetrimide 0.2% w/w.
For a full list of excipient, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A smooth homogenous pink water miscible cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DRAPOLENE Cream is indicated for the prevention and treatment of urinary ammonia dermatitis, particularly nappy
rash, and in the treatment of minor burns and wounds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Children: _Nappy rash. For topical application. To be applied evenly at each nappy change, particular attention being
paid to the folds of the skin.
_Adults: _Urinary Dermatitis. Regular routine application is advised.
_Use in the Elderly: _No special comment.
Minor burns and wounds: Apply as required.
Before applying Drapolene Cream, the affected area should be dry and free from all traces of soap.
4.3 CONTRAINDICATIONS
DRAPOLENE Cream is contraindicated in patients with a hypersensitivity to the active substance or to any of the
excipients (see section 4.4 and 6.1).
Excipient(s)
Wool Fat (purified lanolin)
2.0
%
w/w
Cetyl Alcohol
5.0
%
w/w
Cetostearyl alcohol
4.0
%
w/w
Chlorocresol
0.1
%
w/w
Amaranth (E123)
0.002 %
w/w
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/11/2011_
_CRN 2107998_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DRAPOLENE Cream is for external use only.
Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol and cetostearyl alcohol which may cause local skin
reactions (e.g. contact der
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