ExCetra Cream SPC

Summary of Product Characteristics (SPC)

NAME OF THE  PRODUCT

ExCetra Cream.

PHARMACEUTICAL FORM

Cream.

MAIN INGREDIENTS

white soft paraffin 13.2% w/w and light liquid paraffin 10.5% w/w

THERAPEUTIC INDICATIONS

As an emollient for the relief of dry skin in eczema, psoriasis and other dry skin conditions and for use as a soap substitute for skin washing.

POSOLOGY AND METHOD OF ADMINISTRATION

Adults and Children: ExCetra Cream 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 excess cream to soak in.

CONTRAINDICATIONS

There are no absolute contraindications to the use of ExCetra Cream 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

ExCetra Cream contains no active ingredients and has no pharmacological action.

LIST OF EXCIPIENTS

Purified Water Ph. Eur., Glycerol, Cetosteryl Alcohol, Phenoxyethanol, Trisodium Citrate Dihydrate, Citric Acid Monohydrate, SLS-free emulsifying wax.

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.  500g Flexi-dispenserTM material plastic LDPE, cap PE.

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

None

LEGAL CATEGORY

Medical Device Class 1

BASIC NHS PRICE

ExCetra Cream 100g – £1.75

ExCetra Cream  500g – £2.95

MARKETING AUTHORISATION NUMBER

MD CA016069.

MARKETING AUTHORISATION HOLDER

Dermato Logical Ltd., 31-41, Worship Street, London EC2A 2DX  Tel. 0208 449 2931

ExCetra and Flexi-dispenser  are registered trademarks

Date of text revision: 3.7.2018