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LIP AND COLD SORE RELIEF CREAM

Active substance(s): CETRIMIDE / CHLOROCRESOL / DIMETHICONE 350 / UREA

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SUMMARY OF PRODUCT CHARACTERISTICS 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 PhEur Cetrimide PhEur Dimeticone 350 PhEur Chlorocresol PhEur For a full list of excipients, see section 6.1. 1.0% w/w 0.5% w/w 9.0% w/w 0.1% w/w

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PHARMACEUTICAL FORM
Emollient White Cream

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4.1

CLINICAL PARTICULARS
Therapeutic indications
For the application to cold sores and cracked lips.

4.2

Posology and method of administration
There are no special hazards associated with the use of cetrimide in specific patient groups. No special precautions or modified dosage requirements are, therefore, indicated for its use in infants, the elderly or during pregnancy or lactation. No hazardous drug interactions are considered likely. Adults, elderly and children: apply sparingly every hour for the relief of cold sores and cracked lips.

Topical application.

4.3

Contraindications
Hypersensitivity to urea, cetrimide, dimeticone, chlorocresol or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use
Cymex Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Keep out of the sight and reach of children. For external use only. If symptoms persist consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction None known.

4.6

Pregnancy and lactation
Consult a doctor before use if pregnant or breast-feeding.

4.7

Effects on ability to drive and use machines Not applicable.

4.8

Undesirable effects None.

4.9

Overdose Features Symptoms are unlikely to arise after ingestion of this product. It is possible that nausea and vomiting or diarrhoea may occur. Management

Gut decontamination or other specific management is unlikely to be required. Treat symptomatically. A small glass of milk or water may be helpful.

5.1

Pharmacodynamic properties ATC Code DO 2A X 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.

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6.1

PHARMACEUTICAL PARTICULARS
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 25C.

6.5

Nature and contents of container
5g White Aluminium tubes with Elongated nozzles and HDPE caps. Internally lacquered.

6.6

Special precautions for disposal See 4.2 Posology and Method of Administration.

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MARKETING AUTHORISATION HOLDER
Actavis Group PTC ehf Reykjavkurvegi 76-78 220 Hafnarfjordur Iceland.

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MARKETING AUTHORISATION NUMBER(S)
PL 30306/0028

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/12/2007

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DATE OF REVISION OF THE TEXT
20/11/2012

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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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