Summary of Product Characteristics Updated 23-Nov-2020 | Thornton & Ross Ltd
Oilatum Junior Cream
Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.
Excipient (s) with known effect
Benzyl Alcohol 0.5%w/w
For the full list of excipients, see Section 6.1.
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.
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 may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 0.5% w/w benzyl alcohol which may cause mild local irritation and allergic reactions.
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.
There are no data on the use of topical Oilatum Cream on human fertility
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.
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.
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).
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.
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.
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
Benzyl alcohol (0.5%w/w)
Citric acid monohydrate
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.
Thornton & Ross Ltd.
HD7 5QH, UK
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44 (0) 1484 848164