DERMIDEX Cream 1.2/0.5/0. %w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

LIDOCAINE CETRIMONIUM BROMIDE ALCLOXA CHLOROBUTANOL

Available from:

Thornton & Ross Limited

Dosage:

1.2/0.5/0. %w/w

Pharmaceutical form:

Cream

Authorization date:

2002-08-19

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dermidex Dermatological Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Cream
Smooth white homogenous cream with a characteristic perfume.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults, the elderly and children over 4 years
Apply to the affected area every three hours.
Not suitable for children under four years of age.
4.3 CONTRAINDICATIONS
Known sensitivity to the active constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. Keep out of the reach of children. The product should not be used for longer than seven days
without seeking medical advice.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
Lidocaine
1.20 % w/w
Aluminium chlorhydroxyallantoinate
0.25 % w/w
Chlorobutanol hemihydrate
1.00 % w/w
Cetrimide
0.50 % w/w
For excipients, see 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/05/2006_
_CRN 2023335_
_page number: 1_
4.6 PREGNANCY AND LACTATION
No effects known in pregnancy and lactation. However as with all medicines use with caution.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Occasionally there have been reports of skin reactions with all such preparations.
4.9 OVERDOSE
Overdose is unlikely. If large amounts are ingested, gastric lavage and supportive therapy may be indicated.
5 PHARMACOLOGICAL PROPE
                                
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