SAVLON ANTISEPTIC CREAM
Active substance: STRONG CETRIMIDE SOLUTION 40%
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Cetrimide 0.5% w/w Chlorhexidine Gluconate 0.1% w/w
3
PHARMACEUTICAL FORM
Cream
4
4.1
CLINICAL PARTICULARS
Therapeutic indications The cleansing and prevention of infection in all types of lesions, ranging from minor skin disorders or blisters, to minor burns and small wounds.
4.2
Posology and method of administration For topical use only. Gently smear cream over the affected area.
4.3
Contraindications None known.
4.4
Special warnings and precautions for use For external use only. Keep out of the eyes and ears.
Keep all medicines away from children. If symptoms persist, stop using and consult your doctor.
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Pregnancy and lactation No known restriction.
4.7
Effects on ability to drive and use machines The ability to drive or use machines is not affected.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Chlorhexidine is an effective antiseptic with a wide range of activity against micro organisms, including gram positive and gram negative bacteria, fungi and viruses. Cetrimide is a quaternary ammonium compound with surfactant and antiseptic properties.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data Not applicable.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Cetostearyl alcohol Liquid paraffin Methyl hydroxybenzoate Propyl hydroxybenzoate Antiseptic perfume compound P2419 Purified water
6.2
Incompatibilities None.
6.3
Shelf life
24 months.
6.4
Special Precautions for Storage
Store below 25C.
6.5
Nature and contents of container
Lacquered aluminium tube with a screw cap. Polyethylene/aluminium/polyethylene laminate tube with a multi-layer peel-off tamper evident seal composed of lacquer, aluminium and internal ionomer, closed screw cap. Tubes may be further packaged in unit cardboard boxes. Boxed or unboxed tubes may be provided as items in first aid containers. Pack sizes: 15, 30, 33, 34.5, 36, 40, 60, 66, 100 and 120g.
6.6
Special precautions for disposal Medicines should be kept out of the reach of children.
7
MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited Trading as: Novartis Consumer Health Wimblehurst Road Horsham West Sussex RH12 5AB
8
MARKETING AUTHORISATION NUMBER(S)
PL 00030/0122
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/11/1997 / 11/01/2002
10
DATE OF REVISION OF THE TEXT
09/03/2012
1
NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Cetrimide 0.5% w/w Chlorhexidine Gluconate 0.1% w/w
3
PHARMACEUTICAL FORM
Cream
4
4.1
CLINICAL PARTICULARS
Therapeutic indications The cleansing and prevention of infection in all types of lesions, ranging from minor skin disorders or blisters, to minor burns and small wounds.
4.2
Posology and method of administration For topical use only. Gently smear cream over the affected area.
4.3
Contraindications None known.
4.4
Special warnings and precautions for use For external use only. Keep out of the eyes and ears.
Keep all medicines away from children. If symptoms persist, stop using and consult your doctor.
4.5
Interaction with other medicinal products and other forms of interaction None known.
4.6
Pregnancy and lactation No known restriction.
4.7
Effects on ability to drive and use machines The ability to drive or use machines is not affected.
4.8
Undesirable effects None known.
4.9
Overdose Not applicable.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Chlorhexidine is an effective antiseptic with a wide range of activity against micro organisms, including gram positive and gram negative bacteria, fungi and viruses. Cetrimide is a quaternary ammonium compound with surfactant and antiseptic properties.
5.2
Pharmacokinetic properties Not applicable.
5.3
Preclinical safety data Not applicable.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Cetostearyl alcohol Liquid paraffin Methyl hydroxybenzoate Propyl hydroxybenzoate Antiseptic perfume compound P2419 Purified water
6.2
Incompatibilities None.
6.3
Shelf life
24 months.
6.4
Special Precautions for Storage
Store below 25C.
6.5
Nature and contents of container
Lacquered aluminium tube with a screw cap. Polyethylene/aluminium/polyethylene laminate tube with a multi-layer peel-off tamper evident seal composed of lacquer, aluminium and internal ionomer, closed screw cap. Tubes may be further packaged in unit cardboard boxes. Boxed or unboxed tubes may be provided as items in first aid containers. Pack sizes: 15, 30, 33, 34.5, 36, 40, 60, 66, 100 and 120g.
6.6
Special precautions for disposal Medicines should be kept out of the reach of children.
7
MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited Trading as: Novartis Consumer Health Wimblehurst Road Horsham West Sussex RH12 5AB
8
MARKETING AUTHORISATION NUMBER(S)
PL 00030/0122
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/11/1997 / 11/01/2002
10
DATE OF REVISION OF THE TEXT
09/03/2012
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.
