Full Marks Liquid

1. Name Of The Medicinal Product

Full Marks Phenothrin Liquid.

2. Qualitative And Quantitative Composition

Phenothrin 0.5% w/w.

3. Pharmaceutical Form

Cutaneous emulsion

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of head lice infestations.

4.2 Posology And Method Of Administration

For topical external use only.

The source of infestation should be sought and treated.

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

Rub the emulsion into the scalp until all the hair and scalp are thoroughly moistened. Leave the hair to dry naturally in a warm but well ventilated room. After 12 hours, or the next day, if preferred, shampoo the hair in the normal way.

Rinse the hair and comb whilst wet to remove dead lice and eggs (nits) using a nit comb.

Treatment should be repeated after 7 days.

Children under 6 months:

Under medical supervision only

4.3 Contraindications

Known sensitivity to pyrethroid insecticides. Not to be used on infants less than 6 months except on medical advice.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. For external use only. Keep out of the reach of children. If inadvertently swallowed, a doctor or casualty department should be contacted at once.

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

When 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.

Continued prolonged treatment with this product should be avoided. It should not be used more than once a week for more than three consecutive weeks.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Very rarely, skin irritation has been reported.

4.9 Overdose

It is most unlikely that a toxic dose will be ingested. Treatment consists of gastric lavage, assisted respiration and, if necessary in the event of massive ingestion, administration of atropine together with pralidoxime.

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 Phenothrin Liquid is applied topically to the affected area. A pharmacokinetic study has shown absorption of its active constituent is negligible.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium citrate

Citric acid monohydrate

Emulsifying wax (Lanette Wax SX)

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Perfume HT 52

Diethylene glycol

Dimethyl phthalate

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25^oC and do not refrigerate.

6.5 Nature And Contents Of Container

Amber glass sirop bottle fitted with a polypropylene tamper evident lined cap containing 50, 100 or 200ml of product.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Shake the bottle before use.

7. Marketing Authorisation Holder

Seton Products Limited

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0093

9. Date Of First Authorisation/Renewal Of The Authorisation

19/01/98

10. Date Of Revision Of The Text

14/11/2006