Oilatum Shower Gel Fragrance-Free

1. Name Of The Medicinal Product

Oilatum Shower Gel Fragrance-Free

2. Qualitative And Quantitative Composition

Light liquid paraffin 70.0% w/w

3. Pharmaceutical Form

Gel for topical use

4. Clinical Particulars

4.1 Therapeutic Indications

Oilatum Shower Gel Fragrance-Free is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritis, ichthyosis and related dry skin conditions.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

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

Shower as usual. Apply Oilatum Shower Gel Fragrance-Free 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

Oilatum Shower Gel Fragrance-Free should not be used on greasy skin.

Use care to avoid slipping in the shower.

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 Shower Gel Fragrance-Free 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 in the stratum corneum. This prevents excessive evaporation of water from the skin surface thus improving hydration.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable. The relevant information is given in Section 4 of the Summary of Product Characteristics.

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

For the product as packaged for sale: 3 years

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

High density polyethylene tube fitted with a screw cap. Capacity 25 g, 30 g, 125 g and 150g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Oilatum Shower Gel Fragrance-Free.

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 19494/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

24^th June 1993

10. Date Of Revision Of The Text

15 December 2010