Summary of Product Characteristics (SmPC) - 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
Consult your doctor if symptoms persist
Keep out of the reach of children
For external use only
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
The product is not contraindicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.
4.7 Effects on ability to drive and use machines
None.
Replace cap firmly after use
4.8 Undesirable effects
Skin disorders
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Immune disorders
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
4.9 Overdose
Repeated Topical Application
Frequently repeated topical application on the same site could theoretically lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.
Accidental or Deliberate Ingestion
The product would only be expected to be harmful if orally ingested in very large quantities. This is unlikely due to the unpleasant taste of the product. In such a case the primary concern would be the phenol intake which can cause nausea, vomiting, diarrhoea and headache.
Treatment
Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.
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
10 DATE OF REVISION OF THE TEXT
25/09/2023