Full Marks Mousse

1. Name Of The Medicinal Product

Full Marks Mousse.

2. Qualitative And Quantitative Composition

Phenothrin 0.5% w/w

3. Pharmaceutical Form

Topical mousse.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of head louse infestations.

4.2 Posology And Method Of Administration

Caution: Apply the product in a well ventilated room away from naked flames and lighted objects.

Adults, the elderly and children aged 6 months and above:

For topical external use only.

The source of infestation should be sought and treated.

Family members and close contacts should be inspected and, if found to be infected, treated simultaneously.

Shake the can well and invert to expel the mousse.

For Head Lice:

1. Apply sufficient mousse to dry hair at several points on the scalp; massage into the scalp ensuring no part of the scalp is left uncovered. Pay special attention to the temples and crown of the head. Take care to avoid the eyes.

2. Leave on the head for 30 minutes; do not attempt to dry the hair by artificial means (e.g. electric hair dryers).

3. Wash hair with normal shampoo.

4. While the hair is still wet, comb with an ordinary comb. A fine-toothed louse comb can then be used to remove the dead or dying lice and eggs.

Infants:

Not to be used on infants under 6 months of age except under medical supervision.

4.3 Contraindications

Known sensitivity to phenothrin.

4.4 Special Warnings And Precautions For Use

Children under six months of age should only be treated under medical supervision.

Avoid contact with the eyes.

When Full Marks Mousse is used by a school nurse or other health officer in the mass treatment of large numbers of children, it is advisable that protective plastic or rubber gloves be worn.

Prolonged and repeated application should be avoided. Contains flammable alcohol. Avoid naked flames or lighted objects. Do not use artificial heat (e.g. electric hair dryers).

Full Marks Mousse contains alcohol which may cause wheezing in asthmatic patients or cause inflammation of the skin in patients with severe eczema. If such effects are apparent, patients should use a shampoo formulation.

The treatment may affect permed, pre-rinsed, bleached or coloured hair.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Long term studies have not been performed in humans, therefore as with all drugs, Full Marks Mousse should be used with caution in pregnant and lactating women.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Very rarely, skin irritation may occur. The treatment may affect pre-rinsed, permed, coloured or bleached hair. The alcohol content of the mousse may cause stinging or inflammation in patients with eczema.

4.9 Overdose

This product contains 30% alcohol. In the event of deliberate or accidental consumption, particularly by a child, empty stomach contents by gastric lavage and treat symptomatically as hypoglycaemia may occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Phenothrin is a synthetic pyrethroid insecticide, highly effective against human lice but with an exceptionally low mammalian toxicity.

5.2 Pharmacokinetic Properties

Full Marks Mousse is applied topically to the affected area.

5.3 Preclinical Safety Data

Dermal irritation and eye irritation tests carried out in rabbits showed Full Marks Mousse to be a minimal irritant and did not produce positive criteria in any rabbit.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium citrate

Citric acid (anhydrous)

Emulsifying wax (non-ionic)

Purified water

Ethanol (denatured)

Butane 30

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store at or below 25^oC. Do not puncture the can or expose to direct sunlight. Avoid naked flames or lighted objects. Do not use artificial heat (e.g. electric hair dryers). When empty, dispose of safely as normal household waste.

6.5 Nature And Contents Of Container

Aluminium monobloc aerosol cans with a mousse valve assembly, and a vertical foam spout and cap containing either 50g of product to treat one person, 2 x 50g to treat early re-infestation or 150g of product to treat four persons.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Limited

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0102.

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/98

10. Date Of Revision Of The Text

10/05/2000