4.1. Therapeutic indications

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.

4.2. Posology and method of administration

Posology

Adults, the elderly, children and infants over the age of 1 month - apply to the affected part two or three times daily.

Method of administration

For topical administration.

4.3. Contraindications

Hypersensitivity to white soft paraffin, light liquid paraffin and anhydrous lanolin or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

For external use only

Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl and Propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

If rash develops, use of the product should be discontinued.

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.

The product should not be applied to the mucous membranes or to broken skin.

4.5. Interaction with other medicinal products and other forms of interaction

The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators

4.6. Fertility, pregnancy and lactation

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to white soft paraffin, liquid paraffin and lanolin is negligible. As with all medicines, this product should be used with caution during pregnancy.

Breast-feeding

It is unknown whether soft paraffin, light liquid paraffin and anhydrous lanolin metabolites are excreted in human milk. A risk to the newborns/ infants cannot be excluded. Application of the product to the breast is not recommended during breast feeding.

Fertility

No data on human fertility are available.

4.7. Effects on ability to drive and use machines

The product has no or negligible influence on the ability to drive and use machines

4.8. Undesirable effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely. Should this occur, use of the product should be discontinued.

Adverse events which have been associated with white soft paraffin, light liquid paraffin and anhydrous lanolin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity, Dermatitis allergic

Skin and Subcutaneous Tissue Disorders

Not known

Acne

Reporting 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required. There have been no reports of over dosage with use of this product.