Drapolene Cream Benzalkonium chloride 0.01% w/w Cetrimide 0.2% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzalkonium chloride solution; Cetrimide

Available from:

Ravira Limited

ATC code:

D08AJ; D08AJ01; D08AJ04

INN (International Name):

Benzalkonium chloride solution; Cetrimide

Dosage:

0.01/0.2 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Quaternary ammonium compounds; benzalkonium; cetrimide

Authorization status:

Not marketed

Authorization date:

1983-04-01

Patient Information leaflet

12
PACKAGE LEAFLET: INFORMATION FOR THE USER
DRAPOLENE
®
_CREAM _
Benzalkonium chloride 0.01% w/w, Cetrimide 0.2% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if the symptoms have not resolved or if the
symptoms become worse.
WHAT IS IN THIS LEAFLET:
1.
What Drapolene
®
Cream is and what it is used for
2.
What you need to know before you use Drapolene
®
Cream
3.
How to use Drapolene
®
Cream
4.
Possible side effects
5.
How to store Drapolene
®
Cream
6.
Contents of the pack and other information
1.
WHAT DRAPOLENE
® CREAM IS AND WHAT IT IS USED FOR
Drapolene
®
Cream contains benzalkonium chloride and cetrimide in a non-greasy,
soothing cream.
These are antiseptics that help stop bacteria growing.
Drapolene
®
Cream is used in the prevention, treatment and effective relief of
nappy rash in babies,
from newborn onwards.
Drapolene
®
Cream can also be used for adults with incontinence. It helps treat
and soothe skin that is
sore or likely to become sore because of urine on their skin (urinary
dermatitis).
Drapolene
®
cream can also be used to give soothing, effective relief from minor
burns, such as mild
sunburn and sore skin caused by the effects of weather.
You must talk to a doctor if the symptoms have not resolved or if the
symptoms become worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DRAPOLENE
® CREAM
DO NOT USE DRAPOLENE
® CREAM:
If you are allergic (hypersensitive) to benzalkonium chloride or
cetrimide or any of the other
ingredients of this medicine (listed in section 6).
OTHER MEDICINES AND DRAPOLENE
® CREAM: Dra

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2022
CRN00D3VS
Page 1 of 4
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.
Excipients with known effect:
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
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A smooth homogenous pink water miscible cream for topical application.
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
Posology:
_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.
Method of administration: Topical
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).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
19 September 2022
CRN00D3VS
Page 2 of 4
DRAPOLENE Cream is for external use only.
Not for application to mucosa.
Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol
and cetostearyl alcohol which may cause local skin reactions
(e.g. contact dermatitis) in some people.
Drapolene Cream also contains chlorocresol which may cause allergic
reactions in some people.
4.5 INTERACTION WITH OTHER ME