Sudocrem Antiseptic Healing Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZYL ALCOHOL, BENZYL BENZOATE, BENZYL CINNAMATE, ZINC OXIDE, LANOLIN

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

D02AB

INN (International Name):

BENZYL BENZOATE 1.01 % (W/W) BENZYL CINNAMATE 0.15 % (W/W) ZINC OXIDE 15.25 % (W/W) LANOLIN 4 % (W/W) BENZYL ALCOHOL 0.39 % (W/W)

Pharmaceutical form:

CREAM

Composition:

BENZYL BENZOATE 1.01 % (W/W) BENZYL CINNAMATE 0.15 % (W/W) ZINC OXIDE 15.25 % (W/W) LANOLIN 4 % (W/W) BENZYL ALCOHOL 0.39 % (W/W)

Prescription type:

OTC

Therapeutic area:

EMOLLIENTS AND PROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2006-08-25

Patient Information leaflet

Nappy Rash
•
Eczema
•
Surface Wounds
sunburn
•
minor burns
•
acne
•
bed sores
•
chilblains
LOT
EXP
AAAK9909
Directions:
Apply a thin
layer to the
skin as
required.
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:
Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.
This helps to provide information on the safety of this medicine.
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.
60g
AAAK9909
60g
Directions:
Apply a thin
layer to the
skin as
required.
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.
PEEL HERE
DO NOT
REMOVE
Active Ingredients (% (w/w):
zinc oxide 15.25, benzyl alcohol 0.39,
benzyl benzoate 1.01, benzyl cinnamate
0.15, lanolin (hypo-allergenic) 4.
Keep out of the sight and
reach of children.
Manufacturer/
MA holder: Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands
Tosara Pharma Ltd.
Unit 146 Baldoyle Ind. Est.,
Baldoyle, Dublin 13, Ireland.
MA1060/04201
Revision date October 2018
Revision date October 2018
Revision date October 2018
Nappy Rash
•
Eczema
•
Surface Wounds
sunburn
•
minor burns
•
acne
•
bed sores
•
chilblains
* 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:
N/A
TECHNICAL APPROVAL
min pt size

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing
Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
%w/w
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
Emulsified water in oil cream.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
In the treatment of:
1.
Napkin rash
2.
Eczema
3.
Bedsores
4.
Acne
5.
Minor burns
6.
Surface wounds
7.
Sunburn
8.
Chilblains
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.
Healthcare professionals should be aware that if this product comes
into contact with
dressings, clothing and bedding, the fabric can be easily ignited with
a naked flame.
Patients should be warned of this risk and advised to keep away from
fire when using
this product.
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 v