SUDOCREM ANTISEPTIC HEALING CREAM
Active substance: ZINC OXIDE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION %w/w 15.25 0.39 1.01 0.15 4.00
Zinc oxide, EP Benzyl alcohol, BP Benzyl benzoate, BP Benzyl cinnamate Lanolin (hypoallergenic)
3.
PHARMACEUTICAL FORM Emulsified water in oil cream
4.
4.1.
CLINICAL PARTICULARS
Therapeutic Indications In the treatment of: 1. 2. 3. 4. 5. 6. 7. 8. Napkin rash Eczema Bedsores Acne Minor burns Surface wounds Sunburn Chilblains
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.
4.3.
Contra-indications Hypersensitivity to any of the ingredients.
4.4.
Special Warnings and Special Precautions for Use For external use only and should not be allowed to come into contact with the eyes and the mucous membranes.
4.5. Interactions with other Medicinal Products and other forms of Interaction None known.
4.6.
Pregnancy and Lactation There are no known contraindications.
4.7.
Effects on Ability to Drive and Use Machines Not applicable.
4.8.
Undesirable Effects Side effects include local hypersensitivity occasionally.
4.9.
Overdose
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.
5.
5.1.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties Zinc oxide a dermatological agent with astringent, soothing and protective properties. a local anaesthetic with disinfectant properties. 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. 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. resembles the sebaceous secretions of human skin. The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin.
Benzyl alcohol Benzyl benzoate
Benzyl cinnamate
Lanolin
5.2.
Pharmacokinetic Properties Not applicable.
5.3.
Pre-clinical Safety Data Not applicable.
6.
6.1.
PHARMACEUTICAL PARTICULARS
List of Excipients
Purified Water, EP Sodium Benzoate, BP Paraffin wax Microcrystalline wax Heavy Liquid Paraffin, BP Synthetic Beeswax Sorbitan sesquioleate Propylene glycol, BP Antioxidant (Formulation consisting of Butylated hydroxyanisole (BHA), Citric acid and Propylene Glycol) Linalyl acetate Lavender
6.2.
Incompatibilities None known.
6.3.
Shelf Life Not exceeding 5 years from date of manufacture.
6.4.
Special Precautions for Storage No special precautions for storage.
6.5
Nature and contents of container Pack size
(a) polypropylene jars with polyethylene tamper-evident caps
(1) (2) (3) (4)
60 125 175 250 (5) 400 (6) 750 (7)
(b) polypropylene jar with propylene cap
(1) (2)
25 15
(c) COEX HDPE:LDPE 70:30 plastic tube with flip a clear tamper evident plastic sleeve 6.6. Instruction for Use, Handling and Disposal Not applicable.
(1)
30 top cap covered with
7.
MARKETING AUTHORISATION HOLDER Forest Tosara Limited Unit 146 Baldoyle Industrial Estate Baldoyle Dublin 13 Republic of Ireland
8.
MARKETING AUTHORISATION NUMBER(S) PL 06166/0003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 5 March 2004
10
DATE OF REVISION OF THE TEXT
07/02/2013
1
NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION %w/w 15.25 0.39 1.01 0.15 4.00
Zinc oxide, EP Benzyl alcohol, BP Benzyl benzoate, BP Benzyl cinnamate Lanolin (hypoallergenic)
3.
PHARMACEUTICAL FORM Emulsified water in oil cream
4.
4.1.
CLINICAL PARTICULARS
Therapeutic Indications In the treatment of: 1. 2. 3. 4. 5. 6. 7. 8. Napkin rash Eczema Bedsores Acne Minor burns Surface wounds Sunburn Chilblains
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.
4.3.
Contra-indications Hypersensitivity to any of the ingredients.
4.4.
Special Warnings and Special Precautions for Use For external use only and should not be allowed to come into contact with the eyes and the mucous membranes.
4.5. Interactions with other Medicinal Products and other forms of Interaction None known.
4.6.
Pregnancy and Lactation There are no known contraindications.
4.7.
Effects on Ability to Drive and Use Machines Not applicable.
4.8.
Undesirable Effects Side effects include local hypersensitivity occasionally.
4.9.
Overdose
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.
5.
5.1.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties Zinc oxide a dermatological agent with astringent, soothing and protective properties. a local anaesthetic with disinfectant properties. 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. 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. resembles the sebaceous secretions of human skin. The grade (hypoallergenic) used is manufactured so as to exclude many sensitising substances present in the lanolin.
Benzyl alcohol Benzyl benzoate
Benzyl cinnamate
Lanolin
5.2.
Pharmacokinetic Properties Not applicable.
5.3.
Pre-clinical Safety Data Not applicable.
6.
6.1.
PHARMACEUTICAL PARTICULARS
List of Excipients
Purified Water, EP Sodium Benzoate, BP Paraffin wax Microcrystalline wax Heavy Liquid Paraffin, BP Synthetic Beeswax Sorbitan sesquioleate Propylene glycol, BP Antioxidant (Formulation consisting of Butylated hydroxyanisole (BHA), Citric acid and Propylene Glycol) Linalyl acetate Lavender
6.2.
Incompatibilities None known.
6.3.
Shelf Life Not exceeding 5 years from date of manufacture.
6.4.
Special Precautions for Storage No special precautions for storage.
6.5
Nature and contents of container Pack size
(a) polypropylene jars with polyethylene tamper-evident caps
(1) (2) (3) (4)
60 125 175 250 (5) 400 (6) 750 (7)
(b) polypropylene jar with propylene cap
(1) (2)
25 15
(c) COEX HDPE:LDPE 70:30 plastic tube with flip a clear tamper evident plastic sleeve 6.6. Instruction for Use, Handling and Disposal Not applicable.
(1)
30 top cap covered with
7.
MARKETING AUTHORISATION HOLDER Forest Tosara Limited Unit 146 Baldoyle Industrial Estate Baldoyle Dublin 13 Republic of Ireland
8.
MARKETING AUTHORISATION NUMBER(S) PL 06166/0003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 5 March 2004
10
DATE OF REVISION OF THE TEXT
07/02/2013
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
