Medication Guide App

FULL MARKS LOTION

Active substance: PHENOTHRIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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 and pubic 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 years and over:
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 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.
Treatment should be repeated after 7 days.
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.
Treatment should be repeated after 7 days.
Children under 6 years:
Not recommended.

4.3

Contraindications
An history of sensitivity to pyrethroid insecticides.

4.4

Special warnings and precautions for use
Avoid contact with the eyes. Not recommended in children under the age of six years.
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 if 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, 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, It is advisable to carry out a strand
test, testing a small section of hair, before using this product on the whole 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 human 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°C protected from light.

6.5

Nature and contents of container
Cartoned, clear or amber glass bottles with polyethylene caps and
polyethylene sprinkler inserts containing either 50, 55, 100, 110, 160 or 200
ml of product.

6.6

Special precautions for disposal
None stated.

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 17905/0038

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/11/1995

10

DATE OF REVISION OF THE TEXT
May 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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