Benzyl Benzoate Application BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZYL BENZOATE

Available from:

Bell Sons & Co. (Druggists) Limited Gifford House, Slaidburn Crescent, Southport, Mersyside PR 9 9AL, United Kingdom

ATC code:

P03AX01

INN (International Name):

BENZYL BENZOATE 25 % (W/V)

Pharmaceutical form:

CUTANEOUS SOLUTION

Composition:

BENZYL BENZOATE 25 % (W/V)

Prescription type:

OTC

Therapeutic area:

ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS

Authorization status:

Withdrawn

Authorization date:

2006-05-31

Summary of Product characteristics

 
Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

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 

Cutaneous solution 

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. 

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. 

Page 2 of 3 
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�