Oilatum Cream

Oilatum Cream

Oilatum Junior Cream

Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.

Also contains cetostearyl alcohol and potassium sorbate.

For a full list of excipients, see Section 6.1.

Cream.

A white to off-white cream.

Oilatum Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions.

Oilatum Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss.

Oilatum Cream is suitable for adults, children and the elderly.

Should not be used in patients with known hypersensitivity to any of the ingredients.

Oilatum Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin (WSP-LLP) or to any of the excipients in the preparation.

Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).

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.

None.

Fertility

There are no data on the use of topical Oilatum Cream on human fertility

Pregnancy

There are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to WSP-LLP is low.

Lactation

It is not known if Oilatum Cream is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.

None.

May cause irritation in patients hypersensitive to any of the ingredients.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and < 1/100), rare (≥1/10, 000 and <1/1,000); very rare (<1/10, 000) and not known (cannot be estimated from the available data).

Post-marketing data

Skin and Subcutaneous Tissue Disorders

Rare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation.

Immune System Disorders

Rare: Application site hypersensitivity reactions including application site dermatitis.

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.

Symptoms and signs

The product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Excessive topical application should cause no untoward effects other than greasy skin.

Treatment

In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.

Light Liquid Paraffin and White Soft Paraffin exert an emollient effect by forming an occlusive film which reduces trans-epidermal water loss, thus helping to maintain normal skin humidity levels. Polyvinyl pyrrolidone enhances the strength and longevity of the occlusive film formed by the oil on the skin.

Not applicable.

White Soft Paraffin and Light Liquid Paraffin have been used in pharmaceutical and cosmetic preparations for many years. The formulation contains excipients that are commonly used in such preparations. The safety of these substances is well established by common use over long periods in man.

Macrogol 1000 Monostearate

Cetostearyl alcohol

Glycerol

Potassium sorbate

Benzyl alcohol

Citric acid monohydrate

Povidone

Purified water

None.

Three years.

Store below 25 ^○C

Internally lacquered, membrane sealed aluminium tube fitted with a polypropylene screw cap and packed into a carton. Pack size 40g and 80g.

Internally lacquered, membrane sealed aluminium tube fitted with a polyethylene screw cap and packed into a carton. Pack size 30g and 50g.

Laminate tubes with polypropylene caps packed into cartons. Pack sizes 100g and 150g

And 25g, 50g & 150g in a high density polyethylene tube. Not all pack sizes may be marketed.

None.

Thornton & Ross Ltd.

Linthwaite,

Huddersfield,

HD7 5QH, UK

PL 00240/0467

07/12/2010

29/11/2019