Benzyl Benzoate Application Bp
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. CLINICAL PARTICULARS
4.1 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.
Special warnings and precautions for use
4.4
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. PHARMACOLOGICAL PROPERTIES
5.1
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. PHARMACEUTICAL PARTICULARS
6.1 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 25°C.
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.
6.6 Instructions for use and handling
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd
Gifford House
Slaidbum Crescent
Soutliport
Merseyside
PR9 9AL
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 03105/0058
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 25/07/2005
10. DATE OF REVISION OF TEXT
9th March 2005.