Sudocrem Antiseptic Healing Cream

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

BENZYL ALCOHOL; BENZYL BENZOATE; BENZYL CINNAMATE; ZINC OXIDE; LANOLIN

Tilgjengelig fra:

Forest Tosara Limited

ATC-kode:

D02AB

INN (International Name):

BENZYL ALCOHOL; BENZYL BENZOATE; BENZYL CINNAMATE; ZINC OXIDE; LANOLIN

Legemiddelform:

CREAM

Sammensetning:

BENZYL ALCOHOL 0.39 % (W/W); BENZYL BENZOATE 1.1 % (W/W); BENZYL CINNAMATE 0.15 % (W/W); ZINC OXIDE 15.25 % (W/W); LANOLIN 4 % (W/W)

Resept typen:

OTC

Terapeutisk område:

EMOLLIENTS AND PROTECTIVES

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-08-25

Informasjon til brukeren

Nappy Rash
●
Eczema
●
Surface Wounds
sunburn
●
minor burns
●
acne
●
bed sores
●
chilblains
PL 06166/0003
MA Holder & Manufacturer:
_FOREST TOSARA LTD.,_
_ _
Baldoyle Ind. Est.,
Dublin 13, Ireland.
Warnings: Do not use if allergic to any of the ingredients.
Keep out of the eyes, nose and mouth. If symptoms persist or
if accidentally swallowed seek medical help.
Side effects: Occasionally local irritation occurs. If this
happens seek medical help.
Reporting side effects: If you get any side effects talk to
your doctor or pharmacist. You can report side effects via the
YellowCard Scheme at www.mhra.gov.uk/yellowcard.
This helps to provide information on the safety of this medicine.
Keep out of the sight and reach of children.
Active Ingredients (% (w/w):
zinc oxide 15.25, benzyl
alcohol 0.39, benzyl benzoate 1.01, benzyl cinnamate 0.15,
lanolin (hypo-allergenic) 4. Also contains: purified water, liquid
paraffin, paraffin wax, beeswax, microcrystalline wax, sodium
benzoate, linalyl acetate, propylene glycol, citric acid,
butylated hydroxyanisole, sorbitan sesquioleate, lavender
fragrance.
Revision date Dec 2015
e-mail: [e-mail]
LOT
EXP
AAAH9793
DIRECTIONS: Apply a thin layer to the skin as required.
25g
AAAH9793
P
EEL
H
ERE
D
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EMOVE
* Please note that only Actavis Global Artwork Studios are permitted
to make
changes to the above artwork. No changes are permitted by any 3rd
party
other than added notes and mark ups for required changes.
dimensions:
pharmacode:
date sent: 03.06.15
TECHNICAL APPROVAL
min pt size:
Sudocrem 25g Antiseptic Healing Cream 1 pot Peel and Reseal Label - UK
[e-mail]
print proof no:
item no:
origination date:
originated by:
revision date:
supplier:
technically app. date*: 04.06.15
revised by:
approved for print/date
AAAH9793
3
02.07.15
DR
14.12.15
DR
Forest Tosara (Actavis)
32x82mm
4.3pt
(body copy 6.5pt)
1. Profile
2. Varnish Free
Non Printing Colours
colours/plates
3. Braille
4.
1.
2.
3.
4.
5.
PMS Cool Gray 11
PMS 2665
PMS 2635
PMS 032
SUDOCREM
c
d
e

Preparatomtale

Page 1 of 4
1.
NAME OF THE MEDICINAL PRODUCT
Sudocrem
Antiseptic
Healing
Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
%ww
w/ww
www
ww
Zinc oxide, EP
15.25
Benzyl alcohol, BP
0.39
Benzyl benzoate, BP
1.01
Benzyl cinnamate
0.15
Lanolin (hypoallergenic)
4.00
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Cream.
A smooth, homogeneous, white, water in oil cream with a lavender
odour.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
In the management of various dermatoses, including local skin
reactions associated with
incontinence.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Apply a thin layer with suitable covering where necessary. Renew
application as required.
No distinction is required between indications or between adults,
children and the elderly.
Topical cream for external use only.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
For external use only and should not be allowed to come into contact
with the eyes
and the mucous membranes.
If there is no improvement in the condition or aggravation thereof,
the doctor should be
consulted.
Page 2 of 4
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6.
PREGNANCY AND LACTATION
There are no known contraindications.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8.
UNDESIRABLE EFFECTS
Side effects include local hypersensitivity occasionally.
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 report any suspected
adverse reactions
via ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal.
4.9.
OVERDOSE
No
cases
of
overdose
has
been
reported.
If
large
amounts
are
swallowed
accidentally, this may cause vomitting, diarrhoea, CNS stimulation and
convulsions.
Symptomatic treatment should be provided.
5.
PHARMACOLOG