Oilatum Gel

1. Name Of The Medicinal Product

Oilatum Gel

2. Qualitative And Quantitative Composition

Light liquid paraffin 70% w/w

3. Pharmaceutical Form

Shower gel.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of contact dermatitis, atopic dermatitis, senile pruritus ichthyosis and related dry skin conditions.

4.2 Posology And Method Of Administration

Topical

Adults, children and the elderly:

Oilatum Gel may be used as frequently as necessary. Oilatum Gel should always be applied to wet skin, normally as a shower gel.

Shower as usual. Apply Oilatum Gel liberally to wet skin and massage gently. Rinse briefly and lightly pat the skin dry.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

Take care to avoid slipping in the shower.

Oilatum Gel should not be used on greasy skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

There is no or inadequate evidence of the safety of Oilatum Gel in human pregnancy and lactation. Topical preparations containing light liquid paraffin have been in wide use for many years without apparent ill consequence.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Light liquid paraffin exerts an emollient effect by forming an occlusive oil film on the stratum corneum. This prevents excessive evaporation of water from the skin surface and aids in the prevention of dryness.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyethylene 617A

2-octadodecanol

Polyethylene glycol 400 dilaurate.

Polyoxyethylene 40 sorbital septaoleate

Polyethylene glycol-2-myristyl ether propionate

Polyphenylmethyl siloxane copolymer

Floral spice

6.2 Incompatibilities

None.

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

High density polyethylene tubes of 15g, 25g, 30g, 50g, 60g, 65g, 70g, 75g, 125g and 150g

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Oilatum Gel.

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)

PL 19494/0062

9. Date Of First Authorisation/Renewal Of The Authorisation

7^th November 1991 / 6^th August 2004

10. Date Of Revision Of The Text

14 December 2010