Dermidex Dermatological Cream.

Dermidex Dermatological Cream contains:

Lidocaine 1.20% w/w

Alcloxa 0.25% w/w

Chorobutanol 1.00% w/w

Cetrimide 0.50% w/w

For excipients, see 6.1

Cream. A smooth white cream, free from lumps, non greasy with an even distribution of emulsion droplets.

Antiseptic, anaesthetic, anti-irritant, and emollient agent. For the treatment of mild pain caused by minor skin cuts, scratches and grazes (chapping) and soreness caused by detergents, soaps, deodorants and jewellery and bites and stings.

Adults, Children (age 4 and above) and the Elderly:

Apply to the affected area every 3 hours

Not suitable for children aged less than 4 years.

Route of administration: Cream for cutaneous use.

Dermidex Cream is contraindicated where there is hypersensitivity to cetrimide, chlorobutanol, lidocaine or other local anaesthetics of the amide type, or any of the other ingredients.

For external use only. Keep out of reach and sight of children.

The product should not be used for longer than 7 days without seeking medical advice.

Avoid contact with the eyes.

None known.

Lidocaine crosses the placenta and is distributed into breast milk. As with all medicines use with care.

No or negligible influence.

Occasionally there have been reports of skin reaction with all such preparations.

Overdose is unlikely.

Accidental ingestion may result in anaesthesia of the upper respiratory tract, nausea, vomiting and abdominal discomfort. Ingestion of very large quantities could result in CNS and cardiovascular toxicity. Treatment should be symptomatic and supportive.

Other dermatologicals D11A

Not applicable.

Not applicable

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Cetyl Alcohol

Glyceryl Monostearate

Isopropyl Myristate

Light Liquid Paraffin

Purified Water

Phenoxyethanol

Sorbitol Solution

Stearyl Alcohol 1895

Perfume Sport 14412C

None known

36 months unopened

None

Lacquered covex tube with a low or medium density Polyethylene cap in a carton. Aluminium tubes with a Polyamide internal lacquer, a membrane nozzle fitted with a full skirted, spiked white Polyethylene cap in a carton.

Pack sizes: 3g, 4g, 5g, 7.5g, 10g, 30g & 50g.

For external use only.

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland.

PL 30306/0068

2 December 2002

17/10/11

Not Applicable

Not Applicable