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FULL MARKS MOUSSE

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SUMMARY OF PRODUCT CHARACTERISTICS

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 treatment of head lice 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. The 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 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 products 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 EP
Citric Acid (Anhydrous )EP
Emulsifying Wax (non-ionic) HSE
Purified Water EP
Ethanol (Denatured) HSE
Butane 30 HSE

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store at or below 25° C. 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 conatining either 50g of product to treat one
person or 150g of product to treat four persons.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
SSL International plc
Venus
No 1 Old Park Lane
Trafford Quays
Urmston
Manchester
M41 7HA

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0064

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/03/98

10

DATE OF REVISION OF THE TEXT
27/05/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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