Summary of Product Characteristics last updated on medicines.ie: 18/5/2016
Bepantiseptic First Aid Cream
Bepantiseptic First Aid Cream
Phenol 1.20 % w/w
Chlorhexidine Digluconate Solution to give Chlorhexidine Digluconate 0.25 % w/w
Also contains cetostearyl alcohol 10% w/w.
For a full list of excipients, see section 6.1.
A pink, viscous, homogeneous cream
4.1 Therapeutic indications
In the treatment of minor skin irritations
4.2 Posology and method of administration
Apply as necessary after cleansing for up to 3 days.
Known hypersensitivity to any of the constituents
4.4 Special warnings and precautions for use
If symptoms persist or the condition worsens, consult your doctor
4.5 Interaction with other medicinal products and other forms of interaction
Chlorhexidine is incompatible with anionic agents.
4.6 Pregnancy and lactation
Although use of this product is not contraindicated during pregnancy and lactation, as with all medicines during pregnancy, caution should be exercised.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Spontaneous reports of hypersensitivity reactions (hypersensitivity, anaphylactic reaction, anaphylactic shock) have been made; frequency of these reactions cannot be estimated from the available data.
Rarely irritancy, rashes and other skin conditions 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.
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.
Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.
5.1 Pharmacodynamic properties
Phenol: Antiseptic and local anaesthetic.
Chlorhexidine gluconate: Antiseptic.
5.2 Pharmacokinetic properties
The product has a local action with minimal risk of systemic effects.
5.3 Preclinical safety data
Preclinical safety data on these active ingredients in the literature, have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.
6.1 List of excipients
Light liquid paraffin
Sunset yellow (E110)
Ponceau 4R (E124)
Chlorhexidine is incompatible with anionic agents .
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25'C.
6.5 Nature and contents of container
a) Flexible aluminium tubes internally lacquered fitted with an integral nozzle and a polypropylene cap. 5g, 30g, 33g, 55g or 120g tubes are contained in a boxboard carton.
b) Aluminium laminate tubes for 5g, 30g, 33g or 55g pack sizes consisting of 150μm polyethylene/ 5μm polyacry1ate outer layer, 30μm aluminium and an inner layer of 30 μm polyacrylate/ 60 μm polyethylene, fitted with a HD polyethylene shoulder, an aluminium/EAA/surlyn tamper evident seal, with a polypropylene cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements
Date of first authorisation: 2nd January 1987
Date of last renewal: 2nd January 2007