Summary of Product Characteristics (SPC)
NAME OF THE PRODUCT
Opaque white gel
isopropyl myristate 15% w/w; liquid paraffin 15% w/w.
As an emollient for the relief of dry or chapped skin which may also be itchy or inflamed, in eczema, psoriasis and other dry skin conditions.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children: Isomol Gel should be applied to the skin areas as frequently as required. Smooth into the skin in the direction of hair growth. If necessary, allow time for any excess to soak in.
Isomol may also be used immediately prior to washing, showering or bathing to prevent further drying of the skin .
There are no absolute contraindications to the use of Isomol Gel other than hypersensitivity to any of its ingredients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
PREGNANCY AND LACTATION
No special precautions required.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
REPORTING ADVERSE REACTIONS
Adverse reactions should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should be reported to Dermato Logical on 0208 449 2931
Isomol Gel contains no active ingredients and has no pharmacological action.
LIST OF EXCIPIENTS
Purified Water Ph. Eur., White Soft Paraffin, Liquid Paraffin, Polysorbate 60, Cetosteryl Alcohol, Phenoxyethanol.
100g plastic tubes – 36 months. 500g Flexi-dispenserTM – 36 months.
SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C. Do not Freeze
NATURE AND CONTENTS OF CONTAINER
100g sleeve material plastic LLDPE shoulder material plastic LDPE. Cap PP.
500g Flexi -dspenser TM material plastic LDPE. Cap PP
SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Medical Device Class 1
BASIC NHS PRICE
100g Isomol Gel – £1.99
500g Isomol Gel – £2.92
MARKETING AUTHORISATION NUMBER
MARKETING AUTHORISATION HOLDER
Dermato Logical Ltd., 31-41, Worship Street, London EC2A 2DX Tel. 0208 449 2931
Isomol and Flexi-dispenser are registered trademarks
Date of text revision: July 2018