Summary of Product Characteristics Updated 20-Sep-2019 | Haleon UK Trading Limited
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
Fertility
There are no data on the use of cutaneous light liquid paraffin on human fertility.Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Oilatum Gel is expected to be low.Lactation
It 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.Post-marketing data
Skin and Subcutaneous Tissue Disorders
Rare: Application site reactions including application site irritation, rash, erythema, pruritusImmune System Disorders
Rare: Application site hypersensitivity reactions including applicationsite dermatitisReporting 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.Symptoms and signs
The product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.Treatment
In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.Plastic tubes
High density polyethylene tubes with polypropylene capsPack Sizes 15g, 25g, 30g, 50g, 60g, 65g, 70g, 75g, 125g and 150gLaminate tubes
Polyethylene/ethylene vinyl alcohol co-polymer (EVOH)/polyethylene laminate with a polyethylene shoulder, membrane seal, and a polypropylene cap.Pack Sizes30g, 50g and 150g14/09/2019
The Heights, Weybridge, Surrey, KT13 0NY, UK
0800 783 8881
0800 783 8881