SUDOCREM ANTISEPTIC HEALING CREAM

Active substance: ZINC OXIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Zinc oxide, EP
Benzyl alcohol, BP
Benzyl benzoate, BP
Benzyl cinnamate
Lanolin (hypoallergenic)

3.

%w/w
15.25
0.39
1.01
0.15
4.00

PHARMACEUTICAL FORM
Emulsified water in oil cream

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
In the treatment of:
1.
2.
3.
4.
5.
6.
7.
8.

4.2.

Napkin rash
Eczema
Bedsores
Acne
Minor burns
Surface wounds
Sunburn
Chilblains

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.

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.

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.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Zinc oxide

Benzyl alcohol

a local anaesthetic with disinfectant properties.

Benzyl benzoate

an acaricide and has been used as a pediculicide, insect
repellent and pharmaceutical solubilising agent. It is a
constituent of many natural balsams and is one of the principal
esters of Peru Balsam.

Benzyl
cinnamate

this is the other principal ester of Peru Balsal BPC 1973. It is
synthetised from benzyl alcohol and cinnamic acid which has
antibacterial and antifungal properties. Peru Balsam is
categorised as having a mild antiseptic action because of
cinnamic acid and its derivatives present.

Lanolin

5.2.

a dermatological agent with astringent, soothing and protective
properties.

resembles the sebaceous secretions of human skin. The grade
(hypoallergenic) used is manufactured so as to exclude many
sensitising substances present in the lanolin.

Pharmacokinetic Properties
Not applicable.

5.3.

Pre-clinical Safety Data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Purified Water, EP
Sodium Benzoate, BP
Paraffin wax
Microcrystalline wax
Heavy Liquid Paraffin, BP
Synthetic Beeswax
Sorbitan sesquioleate
Propylene glycol, BP
Antioxidant (Formulation consisting of Butylated hydroxyanisole (BHA),
Citric acid and
Propylene Glycol)
Linalyl acetate
Lavender

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
Not exceeding 5 years from date of manufacture.

6.4.

Special Precautions for Storage
No special precautions for storage.

6.5

Nature and contents of container
Pack size

(a) polypropylene jars with polyethylene tamper-evident caps

60

(2)

125

(3)

175

(4)

(b) polypropylene jar with propylene cap

(1)

250 (5) 400

(1)
(2)

25
15

(c) COEX HDPE:LDPE 70:30 plastic tube with flip

(1)

30
top cap covered with

a clear tamper evident plastic sleeve
6.6.

Instruction for Use, Handling and Disposal
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Forest Tosara Limited
Unit 146 Baldoyle Industrial Estate
Baldoyle
Dublin 13
Republic of Ireland

8.

MARKETING AUTHORISATION NUMBER(S)
PL 06166/0003

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
5 March 2004

10

DATE OF REVISION OF THE TEXT
18/10/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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