Oilatum Junior Cream

1. Name Of The Medicinal Product

Oilatum Junior Cream

2. Qualitative And Quantitative Composition

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.

3. Pharmaceutical Form

Cream.

A white to off-white cream.

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restrictions on the use of Oilatum Junior Cream during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

May cause irritation in patients hypersensitive to any of the ingredients

4.9 Overdose

Accidental ingestion may cause nausea and vomiting. Administer copious quantities of water as required. Excessive topical application should cause no untoward effects other than greasy skin.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 1000 Monostearate

Cetostearyl alcohol

Glycerol

Potassium sorbate

Benzyl alcohol

Citric acid monohydrate

Povidone

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

Pack sizes 25g, 30g, 40g, 50g, 80g, 100g and150g: Three years

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100 and 1150ml: 30 Months

6.4 Special Precautions For Storage

Store below 25 ^○C

6.5 Nature And Contents Of Container

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 and 150g in a high density polyethylene tube.

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.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

Pack sizes 25g, 30g, 40g, 50g, 80g, 100g and 150g: PL 19494/0072

Pack sizes 350ml, 500ml, 1000ml, 1050ml, 1100ml and 1150ml: PL 19494/0076

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation PL 19494/0072: 24^th January 2001/7 December 2010

Date of first authorisation PL19494/0076: 28^th October 2005

10. Date Of Revision Of The Text

PL 19494/0072: 19 August 2011

PL 19494/0076: 22 February 2011