- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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.
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).
Hospital users should follow local procedures and policies for using topical products on in-patients.
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
Citric acid monohydrate
Store below 25 °C
Do not store above 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.
PL 44673/0031350ml 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.
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited980 Great West RoadBrentfordMiddlesexTW8 9GS
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
0800 783 8881
0800 783 8881