Isomol Gel Summary of Product Characteristics (SPC)

Summary of Product Characteristics (SPC)

NAME OF THE  PRODUCT

Isomol Gel

PHARMACEUTICAL FORM

Opaque white gel

MAIN INGREDIENTS

isopropyl myristate 15% w/w; liquid paraffin 15% w/w.

THERAPEUTIC INDICATIONS

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 .

CONTRAINDICATIONS

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

None known.

PREGNANCY AND LACTATION

No special precautions required.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None.

UNDESIRABLE EFFECTS

None known.

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

PHARMACODYNAMIC PROPERTIES

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.

INCOMPATIBILITIES

None known.

SHELF LIFE

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

None

LEGAL CATEGORY

Medical Device Class 1

BASIC NHS PRICE

100g Isomol Gel – £1.99

500g Isomol Gel – £2.92

MARKETING AUTHORISATION NUMBER

MD CA016069.

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