This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.

eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
New eMC coming June 2013...

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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 06/08/2013
SPC Sudocrem Antiseptic Healing Cream


Go to top of the page
1. Name of the medicinal product

Sudocrem Antiseptic Healing Cream


Go to top of the page
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


Go to top of the page
3. Pharmaceutical form

Emulsified water in oil cream


Go to top of the page
4. Clinical particulars

Go to top of the page
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


Go to top of the page
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.


Go to top of the page
4.3 Contraindications

Hypersensitivity to any of the ingredients.


Go to top of the page
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.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known


Go to top of the page
4.6 Pregnancy and lactation

There are no known contraindications.


Go to top of the page
4.7 Effects on ability to drive and use machines

Not applicable


Go to top of the page
4.8 Undesirable effects

Side effects include local hypersensitivity occasionally.


Go to top of the page
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.


Go to top of the page
5. Pharmacological properties

Go to top of the page
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.


Go to top of the page
5.2 Pharmacokinetic properties

Not applicable.


Go to top of the page
5.3 Preclinical safety data

Not applicable


Go to top of the page
6. Pharmaceutical particulars

Go to top of the page
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


Go to top of the page
6.2 Incompatibilities

None known


Go to top of the page
6.3 Shelf life

Not exceeding 5 years from date of manufacture.


Go to top of the page
6.4 Special precautions for storage

No special precautions for storage.


Go to top of the page
6.5 Nature and contents of container

 

 

 

Pack size (g)

(a) polypropylene jars with polyethylene tamper-evident caps

(1)

60

 

(2)

125

 

(3)

175

 

(4)

250

 

(5)

400

 

(6)

750

 

(7)

1000

(b) polypropylene jar with propylene cap

(1)

25

 

(2)

15

(c) COEX HDPE:LDPE 70:30 plastic tube with flip top cap covered with a clear tamper evident plastic sleeve

(1)

30


Go to top of the page
6.6 Special precautions for disposal and other handling

Not applicable


Go to top of the page
7. Marketing authorisation holder

Forest Tosara Limited

Unit 146 Baldoyle Industrial Estate

Baldoyle

Dublin 13

Republic of Ireland


Go to top of the page
8. Marketing authorisation number(s)

PL 06166/0003


Go to top of the page
9. Date of first authorisation/renewal of the authorisation

5 March 2004


Go to top of the page
10. Date of revision of the text

07/02/2013



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/7632/SPC/