Summary of Product Characteristics Updated 05-Jan-2022 | Teva UK Limited
Sudocrem Antiseptic Healing Cream
| % 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.
Emulsified water in oil cream
In the treatment of:
1. Napkin rash
2. Eczema
3. Bedsores
4. Acne
5. Minor burns
6. Surface wounds
7. Sunburn
8. Chilblains
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.
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).
None known.
There are no known contraindications.
Not applicable.
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.
No case of overdose has been reported. If large amounts are swallowed accidentally, this may cause vomiting, 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. |
Not applicable.
Not applicable.
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
None known.
Not exceeding 3 years from date of manufacture.
No special precautions for storage.
| Pack size | ||
| (a) polypropylene jars with polyethylene tamper-evident caps | (1) | 60 |
| (2) | 125 | |
| (3) | 175 | |
| (4) | 250 | |
| (5) | 400 | |
| (b) polypropylene jar with propylene cap | (1) | 25 |
| (2) | 15 | |
| (c) COEX HDPE:LDPE 70:30 plastic tube with flip top cap covered with a clear tamper evident plastic sleeve | (1) | 30 |
Not applicable.
Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom.
PL 00289/2299
5 March 2004
15/12/2021
Field House, Station Approach, Harlow, Essex, CM20 2FB
+44 (0)207 540 7117
www.tevauk.com
+44 (0)207 540 7000
+44 (0) 207 000 1216
0800 590 502
