- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- 11. Legal category
Sudocrem Antiseptic Healing Cream
Zinc oxide Ph.EurBenzyl alcohol BPBenzyl benzoate BPBenzyl cinnamate(Lanolin (hypoallergenic)
For excipients, see 6.1
Emulsified water in oil cream.
In the treatment of:
1. Napkin rash
5. Minor burns
6. Surface wounds
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.
Hypersensitivity to any of the ingredients.
For external use only and should not be allowed to come into contact with the eyes and the mucous membranes.Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
There are no known contraindications.
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.
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.
A dermatological agent with astringent, soothing and protective properties.
a local anaesthetic with disinfectant properties.
acaricide and has been used as a pediculicide, insect repellent and pharmaceutical solubilising agent. It is a constituent of many natural balsam and is one of the principal esters of Peru Balsam
This is the other principal ester of Peru Balsam BPC 1973. It is synthesised 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
Resembles the sebaceous secretions of human skin. The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin
Purified Water, EP
Sodium Benzoate, BP
Heavy Liquid Paraffin, BP
Propylene glycol, BP
Antioxidant (formulation consisting of butylated hydroxyanisole (BHA), citric acid and propylene glycol)
Not exceeding 3 years from date of manufacture
No special precautions for storage
a) Polypropylene jars with polyethylene
b) Polypropylene jars with polyethylene caps
c) Co-ex HDPE:LDPE 70:30 plastic tube with flip top cap, with clear tamper evident plastic sleeve
No special requirements
Forest Tosara Limited
Baldoyle Industrial Estate
20 April 2009
Forest Laboratories UK Limited (a subsidiary of Actavis PLC)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346106
+44 (0)1271 385 200
+44(0)1271 385 257