Savlon Antiseptic Cream

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

For excipients, see section 6.1

3. Pharmaceutical Form

Cream.

A smooth, white, homogenous cream with an antiseptic odour

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

36 months.

6.4 Special Precautions For Storage

Store below 30°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 And Other Handling

Medicines should be kept out of the reach and sight of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

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

1 November 1997

10. Date Of Revision Of The Text

18 August 2010

LEGAL CATEGORY

GSL