Oilatum Emollient

1. Name Of The Medicinal Product

Oilatum Bath Formula

Oilatum Emollient

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 Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. Oilatum Emollient replaces oil and water and hydrates the keratin. Oilatum Emollient is particularly suitable for infant bathing. The preparation also overcomes the problem of cleansing the skin in conditions where the use of soaps, soap substitutes and colloid or oatmeal baths proves irritating.

4.2 Posology And Method Of Administration

Oilatum Emollient should always be used with water, either added to the water or applied to wet skin.

Adult bath:

Add 1-3 capfuls to an 8-inch bath of water, soak for 10-20 minutes. Pat dry.

Infant bath:

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

Skin cleansing:

Rub a small amount of oil into wet skin. Rinse and pat dry.

Where conditions permit, and particularly in cases of extensive areas of dry skin, Oilatum Emollient should be used as a bath oil, ensuring complete coverage by immersion. In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

The product is suitable for use in adults, children and the elderly.

4.3 Contraindications

None

4.4 Special Warnings And Precautions For Use

The patient should be advised to use care to avoid slipping in the bath. If a rash or skin irritation occurs, 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 Emollient 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

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acetylated Lanolin Alcohols

Isopropyl Palmitate

Polyethylene Glycol 400 dilaurate

Polyoxyethylene 40 sorbital septaoleate

Floral Spice

6.2 Incompatibilities

None

6.3 Shelf Life

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

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 19494/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th December 1989 / 8^th July 2008

10. Date Of Revision Of The Text

16 December 2010