Oilatum

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.

None.

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).

Hospital users should follow local procedures and policies for using topical products on in-patients.

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

30 Months

Do not store above 25°C.

350ml and 500ml pump pack: High density polyethylene bottle fitted with a mechanical pump dispenser (polyethylene/ polypropylene components).

1000ml, 1050ml, 1100ml 1150ml pump pack: polypropylene container and lid, fitted with a mechanical pump dispenser (polypropylene components), utilising a follower plate (HDPE).

Not all pack sizes may be marketed.

None

Thornton & Ross Ltd.

Linthwaite,

Huddersfield,

HD7 5QH, UK

PL 00240/0466

28/10/2005

11/10/2019