Sudocrem Antiseptic Healing Cream - Product Information
|Manufacture:||Forest Laboratories, Inc.|
|Condition:||Acne, Bed Sores (Dermal Ulcer), Eczema, Minor Burns, Rash (Skin Rash), Sunburn, Wound Cleansing (Wound Debridement)|
|Ingredients:||zinc oxide, benzyl alcohol, benzyl benzoate, benzyl cinnamate, lanolin (hypoallergenic), purified water, sodium benzoate, paraffin wax, microcrystalline wax, heavy liquid paraffin, synthetic beeswax, sorbitan sesquioleate, propylene glycol, antioxidant, linalyl acetate, lavender|
Name of the Medicinal Product
Sudocrem Antiseptic Healing Cream
Qualitative and Quantitative Composition
|Zinc oxide, EP||15.25|
|Benzyl alcohol, BP||0.39|
|Benzyl benzoate, BP||1.01|
Emulsified water in oil cream
In the treatment of:
- Napkin rash
- Minor burns
- Surface wounds
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.
Hypersensitivity to any of the ingredients.
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.
Interaction with Other Medicinal Products and Other Forms of Interaction
Pregnancy and Lactation
There are no known contraindications.
Effects on Ability to Drive and Use Machines
Side effects include local hypersensitivity occasionally.
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.
|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.|
Preclinical Safety Data
List of Excipients
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 5 years from date of manufacture.
Special Precautions for Storage
No special precautions for storage.
Nature and Contents of Container
|(a) polypropylene jars with polyethylene tamper-evident caps||(1)||60|
|(b) polypropylene jar with propylene cap||(1)||25|
|(c) COEX HDPE:LDPE 70:30 plastic tube with flip top cap covered with a clear tamper evident plastic sleeve||(1)||30|
Special Precautions for Disposal and Other Handling
Marketing Authorisation Holder
Forest Tosara Limited
Unit 146 Baldoyle Industrial Estate
Republic of Ireland
Marketing Authorisation Number(s)
Date of First Authorisation/Renewal of the Authorisation
5 March 2004
Date of Revision of the Text
Company contact details
Forest Laboratories UK Limited (a subsidiary of Actavis PLC)
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346106
Medical Information e-mail
+44 (0)1271 311 200
Medical Information Direct Line
+44(0)1271 385 257