Oilatum Junior

1. Name Of The Medicinal Product

Oilatum Fragrance Free Junior

Oilatum Junior

Oilatum Emollient Unperfumed

Oilatum Unperfumed

Oilatum Fragrance Free

Oilatum Emollient Fragrance Free

2. Qualitative And Quantitative Composition

Light Liquid Paraffin 63.4% w/w

3. Pharmaceutical Form

Liquid bath Additive

4. Clinical Particulars

4.1 Therapeutic Indications

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

Route of administration: Topical

4.2 Posology And Method Of Administration

Oilatum Junior may be used as frequently as necessary. Oilatum Junior should always be used with water, either added to the water or applied to wet skin.

For adults add 1-3 capfuls to an 8 inch bath of water. Soak for 10-20 minutes. Pat dry.

For infants, add ½-2 capfuls to a basin of water. Apply gently over entire body with a sponge. Pat dry.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

Patients should be advised to use care to avoid slipping in the bath. If a rash or skin irritation should occur, stop using the product and consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is no or inadequate evidence of the safety of Oilatum Junior in human pregnancy or lactation, but it has been in wide use for many years without 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

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acetylated Lanolin Alcohols

Isopropyl Palmitate

Polyethylene Glycol 400 dilaurate

Macrogol ester.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

For the product as packaged for sale: 5 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

High density polyethylene bottles with a screw cap. Capacity: 25ml, 150ml, 200ml, 250ml, 300ml, 350ml, 400ml, 500ml, 600ml, 1000ml.

6.6 Special Precautions For Disposal And Other Handling

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

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)

PL19494/0064

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 24^th June 1993

Date of latest renewal: 2^nd July 2004

10. Date Of Revision Of The Text

15 December 2010