We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL, UK
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
Medical Information e-mail: medinfo@forest-labs.co.uk


Summary of Product Characteristics last updated on medicines.ie: 04/10/2013
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

15.25

Benzyl alcohol

0.39

Benzyl benzoate

1.01

Benzyl cinnamate

0.15

Wool Fat (Lanolin (hypoallergenic)

4.00

Excipients: contains 0.48% w/w Sodium Benzoate (E211), 0.33% w/w Propylene glycol (E1520) and 0.01% w/w Butylated hydroxyanisole (E320).

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Cream

A smooth, homogeneous, white, water in oil cream with a lavender odour.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

In the management of various dermatoses, including local skin reactions associated with incontinence.


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 for 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. If there is no improvement in the condition or aggravation thereof, the doctor should be consulted.


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 have been reported. If large amounts are swallowed accidentally, this may cause vomiting, 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.

Lanolin:

resembles the sebaceous secretions of human skin.


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 excipient(s)

Purified Water

Sodium Benzoate (E211)

Paraffin wax

Microcrystalline wax

Liquid Paraffin

Synthetic Beeswax

Sorbitan sesquioleate

Propylene glycol (E1520)

Citric acid

Butylated hydroxyanisole (E320)

Linalyl acetate

Lavender Fragrance


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

Polypropylene jar:

5 years

Plastic tube:

2 years


Go to top of the page
6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.


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

Pack size

(g)

(a) polypropylene jar with polyethylene tamper-evident cap

(1) 60

(2) 125

(3) 250

(4) 400

(b) Plastic COEX tube with grey flip top plastic cap covered with a clear tamper evident plastic sleeve

(1) 30

Not all pack sizes may be marketed.


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

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Forest Tosara Limited

Unit 146

Baldoyle Industrial Estate

Grange Road

Baldoyle

Dublin 13

Ireland


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 247/1/1


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1978

Date of last renewal: 01 April 2008


Go to top of the page
10. DATE OF REVISION OF THE TEXT

July 2009



Link to this document from your website:
http://www.medicines.ie/medicine/3076/SPC/Sudocrem+Antiseptic+Healing+Cream/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
   Zinc Oxide
   Benzyl Benzoate
   Benzyl Alcohol
   Benzyl Cinnamate
   wool fat