SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sudocrem Antiseptic Healing Cream

	%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

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.

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	a dermatological agent with astringent, soothing and protective properties.
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	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.    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 3 years from date of manufacture.

6.4. Special Precautions for Storage

No special precautions for storage.

6.5 Nature and contents of container

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

06/10/2014