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Summary of Product Characteristics |
| 1. |
Trade Name of the Medicinal Product
SUDOCREM ANTISEPTIC HEALING CREAM |
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| 2. |
Qualitative and Quantitative Composition |
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% w/w |
| Zinc oxide, EP |
15.25 |
| Benzyl alcohol, BP |
0.39 |
| Benzyl benzoate, BP |
1.01 |
| Benzyl cinnamate |
0.15 |
| Lanolin (hypoallergenic) |
4.00 | |
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| 3. |
Pharmaceutical Form
Emulsified water in oil cream |
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| 4. |
Clinical Particulars |
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| 4.1 |
Therapeutic Indications
In the treatment of: |
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| 1. |
Napkin rash |
| 2. |
Eczema |
| 3. |
Bedsores |
| 4. |
Acne |
| 5. |
Minor burns |
| 6. |
Surface wounds |
| 7. |
Sunburn |
| 8. |
Chilblains | |
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| 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. |
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| 4.3 |
Contra-indications
Hypersensitivity to any of the ingredients. |
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| 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. |
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| 4.5 |
Interactions with Other Medicaments and Other Forms of Interaction
None known |
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| 4.6 |
Pregnancy and Lactation
There are no known contra-indications. |
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| 4.7 |
Effects on Ability to Drive and Use Machines
Not applicable |
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| 4.8 |
Undesirable Effects
Side effects include local hypersensitivity occasionally. |
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| 4.9 |
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. |
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| 5. |
Pharmacological Properties |
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| 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 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.
Lanolin (hypoallergenic):
Resembles the sebaceous secretions of human skin. The grade used is manufactured so as to exclude many sensitising substances present in the lanolin. |
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| 5.2 |
Pharmacokinetic Properties
Not applicable. |
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| 5.3 |
Preclinical Safety Data
Not applicable |
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| 6. |
Pharmaceutical Particulars |
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| 6.1 |
List of Excipients
Purified Water
Sodium Benzoate
Paraffin wax
Microcrystalline wax
Heavy Liquid Paraffin
Synthetic Beeswax
Sorbitan sesquioleate
Propylene glycol
Antracine 54
Linalyl acetate
Lavender
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| 6.2 |
Incompatibilities
None known |
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| 6.3 |
Shelf Life
5 years |
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| 6.4 |
Special Precautions for Storage
None |
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| 6.5 |
Nature and Contents of Container |
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Pack size (g) |
| a) |
Polypropylene jars with polyethylene |
(1) |
60 |
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tamper-evident caps |
(2) |
125
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(3) |
250 |
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(4) |
400 |
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| b) |
polypropylene jar with polyethylene cap |
(1) |
25 |
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(2) |
15 |
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| c) |
aluminium or laminated plastic aluminium |
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30 |
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tubes with aluminium membrane and |
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plastic cap. |
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| 6.6 |
Instructions for Use/Handling
Not applicable |
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| 7. |
Marketing Authorisation Holder
Forest Tosara Limited,
Unit 146 Baldoyle Industrial Estate,
Dublin 13,
Republic of Ireland.
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| 8. |
Marketing Authorisation Number
PL 3430/0001R |
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| 9. |
Date of First Authorisation/Renewal of Authorisation
Renewal August 1996 |
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| 10. |
Date of (Partial) Revision of the Text
September 1996 |
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| 11. |
Legal Category
GSL |
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