Please refer to the Summary of Product Characteristics (SmPC) for full details of Prescribing Information.
Sudocrem Antiseptic Healing Cream Abbreviated Prescribing Information. Presentation: Smooth, homogeneous, white, water in oil cream with a lavender odour. Excipients with known effect: sodium benzoate, propylene glycol, butylated hydroxyanisole. Indications: In the management of various dermatoses, including local skin reactions associated with incontinence. Dosage and administration: Topical cream for external use only. 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. Contraindications: Hypersensitivity to any of the active substances or excipients. Precautions and warnings: 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. Contains sodium benzoate which may cause non-immunologic immediate contact reactions by a possible cholinergic mechanism. Absorption through the immature skin of neonates is significant and may increase jaundice in this population. Contains butylated hydroxyanisole which may cause local skin reactions (e.g. contact dermatitis), irritation to the eyes and mucous membranes. Contains propylene glycol which may cause skin irritation. This medicine should not be used in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns). Interactions: None known. Pregnancy and lactation: There are no known contraindications. Effects on ability to drive and use machines: Not applicable. Adverse reactions: Side effects include local hypersensitivity occasionally. Consult the Summary of Product Characteristics in relation to other side effects. 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. Legal category: GSL. Marketing Authorisation Number: PA0436/054/001. Marketing Authorisation Holder: Norton Waterford T/A IVAX Pharmaceuticals Ireland, Unit 301, IDA Industrial Park, Cork Road, Waterford, Ireland. Job Code: MED-IE-00098. Date of Preparation: May 2025.
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