Eczmol 1% cream

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Chlorhexidine gluconate

MAH:

Genus Pharmaceuticals Ltd

ATC_code:

D08AC02

INN:

Chlorhexidine gluconate

dosage:

10mg/1gram

pharmaceutical_form:

Cutaneous cream

administration_route:

Cutaneous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 13110200; GTIN: 5030451004345

PIL

PEEL HERE
BUT DO NOT
REMOVE
ECZMOL
™
250ml
1% W/W CREAM
Chlorhexidine Gluconate
FOR USE AS A SOAP SUBSTITUTE – use in place of an ordinary
soap or shower gel. Ensure the water is warm but not too
hot as this can remove your skin’s natural oils. Pat dry with
a soft towel after washing. Avoid rubbing too much as this
can make dry skin conditions worse.
THIS PRODUCT CONTAINS CETOSTEARYL ALCOHOL WHICH MAY
CAUSE LOCAL SKIN REACTIONS (E.G. CONTACT DERMATITIS).
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30°C.
ACTIVE INGREDIENT: Chlorhexidine gluconate 1% w/w
(incorporated as Chlorhexidine Gluconate Solution 5% v/w).
ALSO CONTAINS: cetostearyl alcohol, macrogol cetostearyl
ether, isopropyl alcohol, liquid paraffin, white soft paraffin
and water.
MA HOLDER: Genus Pharmaceuticals, Linthwaite,
Huddersfield, HD7 5QH, UK
PL 06831/0242
92434492002
Read all of this label carefully before you start using this
medicine because it contains important information for
you.
USES: Eczmol is a moisturising and antimicrobial
emollient cream, which can also be used as an
alternative to soap. It forms a protective barrier on the
skin and helps to retain moisture in deeper layers of the
skin. This helps to prevent and treat dryness and itching
which are common problems for people with eczema and
dry skin conditions.
The active ingredient, chlorhexidine gluconate, is an
antimicrobial which helps combat germs on the skin that
make certain types of eczema worse.
DIRECTIONS FOR USE:
Do not use if tamper evident collar is broken or missing
at first use. Prime the pump before first use by
depressing fully until cream appears. If the pump stops
working do not dismantle the pack. Re-start by covering
the nozzle, then fully depress the pump several times to
expel air.
ECZMOL CREAM IS FOR EXTERNAL USE ON THE SKIN ONLY.
Adults, the elderly, infants and children:
FOR APPLICATION TO THE SKIN – apply the cream to the
affected area and massage into the skin until absorbed.
Repeat as often as required.
5 030451 004345
BEFORE YOU

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eczmol 1% w/w Cream
Cetraben Protect Antimicrobial 1% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 1% w/w.
(incorporated as Chlorhexidine Gluconate Solution 5.0 % v/w)
Excipient(s) with known effect
Cetostearyl alcohol 2% w/w
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream
A white, smooth, pourable cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eczmol/Cetraben Protect Cream is an antimicrobial emollient which can
also be used
as an alternative to soap in the management of dry and pruritic skin
conditions
including eczema and dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use. For external use only.
For adults, the elderly, infants and children
FOR APPLICATION TO THE SKIN
Apply to the affected areas as often as necessary.
FOR USE AS A SOAP SUBSTITUTE
Eczmol/Cetraben Protect Cream may also be used as a cleanser in the
bath or shower,
or for other toiletry purposes, instead of ordinary soap or shower
gel.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the product or any of its components,
especially in those
with a history of possible Chlorhexidine-related allergic reactions
(see section 4.4 and
4.8)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Eczmol/Cetraben Protect Cream contains chlorhexidine. Chlorhexidine is
known to
induce hypersensitivity, including generalised allergic reactions and
anaphylactic
shock. The prevalence of chlorhexidine hypersensitivity is not known,
but available
literature suggests this is likely to be very rare.
Eczmol/Cetraben Protect Cream should not be administered to anyone
with a
potential history of an allergic reaction to a
chlorhexidine-containing compound (see
sections 4.3 and 4.8).
For topical application only. Keep out of the eyes and ears and avoid
contact with the
brain and meninges.
Hypersensitivity to some of the ingredients of Eczmol/Cetraben Protect
Cream may
be more common in patients with leg ulcer or stasis dermatitis. Th