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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL

Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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Summary of Product Characteristics last updated on the eMC: 23/03/2010

SPC	Sudocrem Antiseptic Healing Cream

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. Legal Category

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1. NAME OF THE MEDICINAL PRODUCT

Sudocrem Antiseptic Healing Cream

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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

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3. PHARMACEUTICAL FORM

Emulsified water in oil cream

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4. CLINICAL PARTICULARS

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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

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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.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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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.

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4.5 Interaction with other medicinal products and other forms of interaction

None known

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4.6 Pregnancy and lactation

There are no known contraindications.

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4.7 Effects on ability to drive and use machines

Not applicable

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4.8 Undesirable effects

Side effects include local hypersensitivity occasionally.

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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.

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5. PHARMACOLOGICAL PROPERTIES

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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 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.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

Not applicable

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Purified Water

Sodium Benzoate

Paraffin wax

Microcrystalline wax

Heavy Liquid Paraffin

Synthetic Beeswax

Sorbitan sesquioleate

Propylene glycol

Antioxidant (formulation consisting of butylated hydroxyanisole (BHA), citric acid and propylene glycol)

Linalyl acetate

Lavender

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6.2 Incompatibilities

None known

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6.3 Shelf life

Not exceeding 5 years from date of manufacture.

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6.4 Special precautions for storage

No special precautions for storage.

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6.5 Nature and contents of container

			Pack size (g)
a)	Polypropylene jars with polyethylene tamper-evident caps	(1)	60
	Polypropylene jars with polyethylene tamper-evident caps	(2)	125
		(3)	250
		(4)	400
		(5)	750
		(6)	1000

b)	Polypropylene jars with polyethylene caps	(1)	15
		(2)	25

c)	Aluminium or laminated plastic aluminium tubes with aluminium membrane and plastic caps	(1)	30
		(2)	50