Summary of medicine characteristics - DERMACREME OINTMENT
1 NAME OF THE MEDICINAL PRODUCT
Dermacreme Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide 8.0% w/w
Menthol 0.015% w/w
Methyl Salicylate 3.0% w/w
Liquefied Phenol 1.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cuts, grazes, minor burns and scalds.
4.2 Posology and method of administration
Adults (all ages) and Children – Apply directly to the affected parts.
4.3 Contraindications
Hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
May cause local skin reactions (e.g.contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction None.
4.6 Pregnancy and lactation
May be used.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Local allergic reactions may occur. Very rarely, contact dermatitis may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No cases known.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Menthol has analgesic and antipruritic actions. Methyl Salicylate relieves pain. Liquefied Phenol has bacteriostatic and local anaesthetic actions. Zinc Oxide has protective actions and is also a soothing and mild astringent.
5.2 Pharmacokinetic properties
No information available.
5.3 Preclinical safety data
No information available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dispersed Pink 11150/Erythrosine (E127)
Yellow Soft Paraffin
Starch
Lanolin Anhydrous
Hard Paraffin
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Polyethylene jar with hard plastic screwcap: 30g.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
BELL SONS & COMPANY (DRUGGISTS) LIMITED
GIFFORD HOUSE
SLAIDBURN CRESCENT
SOUTHPORT
MERSEYSIDE
PR9 9AL
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19th September 2007