This information is intended for use by health professionals
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it
FertilityThere are no data on the use of cutaneous light liquid paraffin on human fertility.
PregnancyNo effects during pregnancy are anticipated, since systemic exposure to Oilatum Gel is expected to be low.
LactationIt is not known if Oilatum Gel is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.
Skin and Subcutaneous Tissue DisordersRare: Application site reactions including application site irritation, rash, erythema, pruritus
Immune System DisordersRare: Application site hypersensitivity reactions including applicationsite dermatitis
Reporting of suspected adverse reactionsReporting 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.
Symptoms and signsThe product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.
TreatmentIn case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.
Plastic tubesHigh density polyethylene tubes with polypropylene capsPack Sizes 15g, 25g, 30g, 50g, 60g, 65g, 70g, 75g, 125g and 150g
Laminate tubesPolyethylene/ethylene vinyl alcohol co-polymer (EVOH)/polyethylene laminate with a polyethylene shoulder, membrane seal, and a polypropylene cap.Pack Sizes30g, 50g and 150g