FULL MARKS LOTION
Active substance: PHENOTHRIN
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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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 30C 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
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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 30C 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
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
