This information is intended for use by health professionals

1. Name of the medicinal product

Sudocrem Antiseptic Healing Cream

2. Qualitative and quantitative composition

% w/w

Zinc oxide Ph.Eur

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 for adults, children and the elderly.

Topical cream for external use only.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and 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 Interaction 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported. If large amounts are swallowed accidentally, this may cause vomiting, diarrhoea, CNS stimulation and convulsions. Symptomatic treatment should be provided.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Zinc Oxide:

A dermatological agent with astringent, soothing and protective properties.

Benzyl alcohol:

a local anaesthetic with disinfectant properties.

Benzyl benzoate:

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

Benzyl cinnamate:

This is the other principal ester of Peru Balsam BPC 1973. It is synthesised 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:

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

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical 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 3 years from date of manufacture

6.4 Special precautions for storage

No special precautions for storage

6.5 Nature and contents of container

 

a) Polypropylene jars with polyethylene tamper-evident caps

 

 

(1)

(2)

(3)

(4)

(5)

Pack size

(g)

60

125

175

250

400

b) Polypropylene jars with polyethylene caps

(1)

(2)

25

15

c) Co-ex HDPE:LDPE 70:30 plastic tube with flip top cap, with clear tamper evident plastic sleeve

(1)

30

6.6 Special precautions for disposal and other handling

No special requirements

7. Marketing authorisation holder

Forest Tosara Limited

Baldoyle Industrial Estate

Grange Road

Baldoyle

Dublin 13

8. Marketing authorisation number(s)

PL 06166/0003

9. Date of first authorisation/renewal of the authorisation

20 April 2009

10. Date of revision of the text

10/07/2017

LEGAL CATEGORY

GSL