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BENZYL BENZOATE APPLICATION BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Benzyl Benzoate Application BP.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Benzyl Benzoate BP 25.00% w/v.

3.

PHARMACEUTICAL FORM Lotion External use.

4. 4.1

CLINICAL PARTICULARS Therapeutic indications Benzyl benzoate is used for the treatment of scabies.

4.2

Posology and method of administration For application to the skin. Apply over the whole body, omitting the head and neck; repeat without bathing on the following day and wash off 24 hours later; a third application may be required in some cases. Not recommended for use in children. Dilution to reduce irritant effect also reduces efficacy.

4.3

Contraindications Hypersensitivity to benzyl benzoate.

4.4

Special warnings and precautions for use Avoid contact with the eyes and mucous membranes, do not use on broken or secondarily infected skin.

4.5

Interactions with other medicinal products and other forms of interaction None known.

4.6

Pregnancy and lactation No information of safety in pregnancy and lactation. Use with caution.

4.7

Effects on ability to drive and use machines None known.

4.8

Undesirable effects Irritation of skin, eyes and mucous membranes; burning sensation especially on genitalia and excoriations. Occasional rashes.

4.9

Overdose When ingested, benzyl benzoate may cause stimulation of the CNS and convulsions. Treatment of poisoning involves gastric lavage and appropriate symptomatic measures.

5. 5.1

PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties Benzyl benzoate is an acaracide, used in the treatment of scabies.

5.2

Pharmacokinetic properties Not applicable to this product.

5.3

Preclinical safety data In experimental animals, ingestion of benzyl benzoate leads to progressive incoordination, excitation, convulsions and death. There is no evidence of mutagenicity or teratogenicity.

6. 6.1

PHARMACEUTICAL PARTICULARS List of excipients Emulsifying wax Phenoxyethanol Nipasept Carbomer Copolymer Sodium Hydroxide Water, purified

6.2

Incompatibilities None known.

6.3

Shelf life Two years.

6.4

Special precautions for storage Store below 25C. Protect from light.

6.5

Nature and contents of container

Opaque 500 ml, 1000 ml and 2000 ml HDPE bottles or 100 ml, 200 ml, 500 ml and 2000 ml amber glass bottles.

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Instructions for use and handling Not applicable.

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MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd Gifford House Slaidbum Crescent Soutliport Merseyside PR9 9AL United Kingdom

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MARKETING AUTHORISATION NUMBER PL 03105/0058

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/07/2005 DATE OF REVISION OF TEXT 9th March 2005.

10.

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