Summary of Product Characteristics (SmPC) - Sudocrem Antiseptic Healing cream
1 NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
% w/w Zinc oxide 15.29 Benzyl alcohol 0.39 Benzyl benzoate 1.02 Benzyl cinnamate 0.15 Lanolin (hypoallergenic) 4.02
Excipient(s) with known effect
Sodium benzoate 0.48% w/w
For the full list of excipients, see section 6.1.
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.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Excipient
Sodium benzoate may cause local irritation and may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, 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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
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
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
60g, 125g, 175g, 250g and 400g polypropylene pots closed with polyethylene tamper evident caps
45g, 75g, 150g, 300g and 425g polypropylene pots closed with polyethylene tamper evident caps with a hinge
15g polypropylene jars with propylene caps
30 g COEX HDPE/LDPE 70:30 plastic tubes with flip top caps covered with a clear tamper evident plastic sleeve
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/2299
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
5 March 2004
10 DATE OF REVISION OF THE TEXT
04/04/2023