Isomol Gel Summary of Product Characteristics (SPC)

Summary of Product Characteristics (SPC)

NAME OF THE PRODUCT

Isomol Gel.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Isopropyl Myristate 15% w/w, Liquid Paraffin 15% w/w

PHARMACEUTICAL FORM

Gel

THERAPEUTIC INDICATIONS

A highly moisturising gel for regular and frequent use 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, smoothing gently into the affected areas in the direction of hair growth, or as directed by your doctor, pharmacist or nurse. Isomol Gel may also be used before or after washing 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.

If the skin is broken, badly cracked, infected or bleeding, check with a doctor before use.

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

Local skin reactions can occur in rare cases. In this event, treatment should be discontinued.

PHARMACODYNAMIC PROPERTIES

Isomol Gel contains Isopropyl Myristate and Liquid Paraffin which encourage rehydration and softening of dry skin.

LIST OF EXCIPIENTS

Glycerol, Carbomer, Polysorbate 20, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Purified Water

INCOMPATIBILITIES

None known.

SHELF LIFE

100g plastic tubes – 36 months. “Easy Squeeze” 500g  flexi dispenser™ – 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.  “Easy Squeeze” 500g Flexi Dispenser™ material plastic LDPE. Cap PP

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

None

LEGAL CATEGORY

N/A

BASIC NHS PRICE

100g Isomol Gel – £1.99

500g Isomol Gel – £2.92

MARKETING AUTHORISATION NUMBER

MD CA012535.

MARKETING AUTHORISATION HOLDER

Dermato Logical Ltd., Laser House, 132-140 Goswell Road, London EC1V 7DY  Tel. 0208 449 2931

Isomol™ &  Flexi Dispenser™ are registered trade marks