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Description

E45 Cream

2. Qualitative and quantitative composition
Anhydrous Lanolin 1.0% w/w
White Soft Paraffin BP 14.5% w/w
Light Liquid Paraffin PhEur 12.6% w/w
Excipient(s) with known effect:

Cetyl alcohol

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

For the full list of excipients, see section 6.1

3. Pharmaceutical form
A cream

Smooth cream, white or practically white with a slight odor.

4. Clinical particulars
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
If a rash develops, the use of the product should be discontinued.

Instruct patients not to smoke or go near naked flames – the 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.

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. The application of the product to the breast is not recommended during breastfeeding.

 

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