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SAVLON ANTISEPTIC CREAM

Active substance: STRONG CETRIMIDE SOLUTION 40%

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Transcript
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

CLINICAL PARTICULARS

4.1

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

PHARMACOLOGICAL PROPERTIES

5.1

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

PHARMACEUTICAL PARTICULARS

6.1

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 25°C.

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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