1. NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
%w/w
Zinc oxide, EP 15.25
Benzyl alcohol, EP 0.39
Benzyl benzoate, EP 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 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.
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.
4.9 Overdose
No case 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: 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 (hypo allergenic) 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 EP
Paraffin Wax
Microcrystalline wax
Liquid Paraffin EP
Synthetic Beeswax
Sorbitan Sesquioleate EP
Propylene glycol EP
Citric acid
Butylated hydroxyanisole
Linalyl acetate
Lavender
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Not exceeding 5 years from date of manufacture.
6.4 Special precautions for storage
No special precautions for storage.
6.5 Nature and Contents of Containers
(a) polypropylene jars with polyethylene tamper-evident caps.
Pack size
(1) 60g
(2) 125g
(3) 250g
(4) 400g
(b) polypropylene jars with polyethylene cap.
Pack size
(1) 25g
(2) 10g
6.6 Instructions for Use, Handling and Disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Forest Tosara Limited
Unit 146 Baldoyle Industrial Estate
Grange Road
Baldoyle
Dublin 13
8. MARKETING AUTHORISATION NUMBER
PL 06166/0003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05 March 2004.
10. DATE OF REVISION OF THE TEXT
Revision April 2002.
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