Full Marks Lotion

1. Name Of The Medicinal Product

Full Marks Lotion.

2. Qualitative And Quantitative Composition

Full Marks Lotion contains:

Phenothrin 0.2% w/v

3. Pharmaceutical Form

Lotion

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of head lice and pubic lice infestation.

4.2 Posology And Method Of Administration

For topical external use only.

The source of infestation should be sought and treated.

For adults, the elderly, and children aged over 6 months

For head lice:

1. Sprinkle the lotion on the hair and rub gently onto the head until the entire scalp is moistened. Pay special attention to the back of the neck and the area behind the ears. Take care to avoid the eyes.

2. Allow to dry naturally. Use no heat.

3. The hair may be washed with a standard shampoo 2 hours after application.

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

For pubic lice:

Application and dosage etc. are as for the head. Apply the lotion to the pubic hair and the hair between the legs and around the anus. Allow to dry naturally, using no heat.

4.3 Contraindications

A history of sensitivity to pyrethroid insecticides.

4.4 Special Warnings And Precautions For Use

Do not use in children aged under 6 months except under medical supervision.

Do not use on broken or secondarily infected skin.

Full Marks Lotion contains isopropyl 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.

Contains flammable alcohol. Apply and dry with care. Avoid naked flames or lighted objects. Do not use artificial heat (e.g. electric hairdryers). Dry in a well ventilated room. Do not cover the head before the lotion has dried completely. The hair should be dry before retiring to bed.

When Full Marks Lotion 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 repeated use with this product should be avoided. It should not be used more than once a week, and for not more than three consecutive weeks.

This treatment may affect permed, pre-rinsed, coloured or bleached hair. If your hair has been permed, pre-rinsed, coloured or bleached, Full Marks Lotion should be applied to a small section of hair for 30 minute, and checked for any reaction, before applying the treatment to a full head.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

There are no known effects in pregnancy and lactation. However, as with all drugs, Full Marks Lotion should be used with caution in pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Some patients may experience stinging or inflammation of the skin due to the alcohol content.

4.9 Overdose

In the event of deliberate or accidental ingestion, as for ethyl alcohol, empty the stomach by gastric lavage and treat symptomatically.

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

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Herbal Green Bouquet P15312

Isopropanol

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store bottle in carton at or below 30^oC protected from light.

6.5 Nature And Contents Of Container

Cartoned, clear or amber glass bottles with polyethylene caps and polypropylene sprinkler inserts containing either 50, 55, 110, 160 or 200 ml of product.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Seton Products Ltd

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0047.

9. Date Of First Authorisation/Renewal Of The Authorisation

27/11/1995.

10. Date Of Revision Of The Text

September 2006