Oilatum Plus

1. Name Of The Medicinal Product

Oilatum Plus

Oilatum Junior Flare-Up

2. Qualitative And Quantitative Composition

Light liquid paraffin 52.5% w/w, benzalkonium chloride solution 12.0% w/w, triclosan 2% w/w

3. Pharmaceutical Form

Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Topical as a bath additive.

For the prophylactic treatment of eczemas at risk from infection.

4.2 Posology And Method Of Administration

Oilatum Plus must always be used diluted in water. It is an effective cleanser and should not be used with soap.

Use once daily. Do not exceed the recommended dose:

Adults and children: In an eight inch bath add 2 capfuls, in a four inch bath add 1 capful

Infants: Add 1 ml (just sufficient to cover the bottom of the cap) and mix well with water.

Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

Do not use for babies younger than 6 months

4.3 Contraindications

Patients with a known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

Oilatum Plus contains benzalkonium chloride which is irritant and may cause skin reactions.

Avoid contact of the undiluted product with the eyes and skin.

If the undiluted product comes into contact with the eye, reddening may occur. Eye irrigation should be performed for 15 minutes and then the eye examined under fluorescein stain. If there is persistent irritation or any uptake of fluorescein, the patient should be referred for ophthalmological opinion.

If undiluted product is applied directly to the skin, it may cause application site skin irritation and hypersensitivity reactions including skin exfoliation, pain, blister, caustic injury and necrosis.

The patient should be advised to use care to avoid slipping in the bath.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No restrictions on the use of the product in pregnancy and lactation are proposed.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Post-marketing data

Skin and subcutaneous tissues disorders

• Erythema, pruritus, skin reactions, contact dermatitis, atopic dermatitis , skin burning sensation

Immune System disorders

• Application site hypersensitivity

4.9 Overdose

The product is intended for topical use only. Accidental ingestion may cause gastro intestinal irritation with vomiting and diarrhoea. Vomiting may result in foam aspiration. In the case of accidental ingestion, give 1 to 2 glasses of milk or water to drink. If a large quantity of the product is ingested, the patient should be observed in hospital and the use of activated charcoal may be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzalkonium chloride and triclosan are anti-bacterial agents with proven efficacy against Staphylococcus aureus, the principal causative organism in infected eczemas.

Light liquid paraffin is an emollient widely used in the treatment of eczema.

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

Oleyl alcohol

Polyoxyethylene lauryl ether

6.2 Incompatibilities

None known.

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

None.

6.5 Nature And Contents Of Container

White polyvinyl chloride or high density polyethylene bottles containing 20ml, 25ml, 150ml, 250ml, 350ml, 500ml, 600ml, 1000ml with white urea cap.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Oilatum Plus/Oilatum Junior Flare-Up.

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 19494/0060

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 16^th February 1990

Date of latest renewal: 25^th February 2009

10. Date Of Revision Of The Text

14 December 2010