Cymex Cream

1. Name Of The Medicinal Product

Cymex Cream

Own Label Supplier:

Superdrug Lip & Cold Sore Cream

Lip and Cold Sore Relief Cream

2. Qualitative And Quantitative Composition

Urea BP	1.0% w/w
Cetrimide BP	0.5% w/w
Dimeticone 350 BPC	9.0% w/w
Chlorocresol BP	0.1% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Emollient White Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the application to cold sores and cracked lips.

Topical Application Only.

4.2 Posology And Method Of Administration

Apply sparingly every hour for the relief of cold sores and cracked lips.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Keep out of the reach of children.

For External use only.

If symptoms persist consult a Doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Can be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None.

4.9 Overdose

Not known.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Urea has keratolytic properties, Cetrimide is a quaternary ammonium disinfectant, Chlorocresol is a mild disinfectant while Dimeticone 350 acts as a water repellent.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No particular remarks.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Deionised Water

Liquid paraffin BP

Cetosteryl Alcohol BP

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

5 g White Aluminium tubes with Elongated nozzles and HDPE caps. Internally lacquered.

6.6 Special Precautions For Disposal And Other Handling

See 4.2 Posology and Method of Administration.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

Own label supplier:

Superdrug Stores plc

Admail 838

Croydon

Surrey

CR9 4WZ

England

Own label supplier:

Boots the Chemist plc

1 Thane Road

Nottingham

NG2 3AA

England

8. Marketing Authorisation Number(S)

PL 30306/0028

9. Date Of First Authorisation/Renewal Of The Authorisation

13^th December 2007

10. Date Of Revision Of The Text

04/05/2010

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)