1 ml of the emulsion contains benzyl benzoate 250 mg

For the full list of excipients, see section List of excipients.

Emulsion for topical use.

A white emulsion with specific odor.

Therapeutic indications

Benzyl Benzoate is an acaricide used in the treatment of scabies and pediculosis.

Topical use, Cutaneous use.

Scabies: Apply thoroughly to the entire body at night from the soles of the feet, omitting the head and neck, for 2 consecutive nights. The emulsiom is left in place for 8-12 hours on each night and may be followed by a repeated application at night 7 days later. In the case of lesions affecting the head, face and/or neck, it may be necessary to consult a healthcare professional before using this product. Thorough bathing with complete changes of clothing and bedding should follow each application. All contacting clothes and bedding should be washed and/or cleaned.

Pediculosis: Apply to the affected area and allow to remain on for 24 hours, then wash thoroughly. In severe cases 2 or 3 treatments may be repeated after 7 and 14 days.

Thorough bathing with complete changes of clothing should follow each application. All contacting clothing and bedding should be washed and or cleaned

Child and Infant Dosage Instructions:

Benzyl Benzoate may be diluted with an equal quantity of water for older children and with three parts of water for infants.

Use in patients with a known hypersensitivity to benzyl benzoate or any of the other ingredients of this medicine listed in section Pharmaceutical particulars.

Local erythema and irritation may occur.

Benzyl benzoate must not be allowed to come into contact with mucous membranes and eyes.

Benzyl benzoate causes little skin irritation, but may cause a transient burning sensation. This is usually mild, but can occasionally be severe in sensitive individuals. In the event of a severe skin reaction the preparation should be washed off using soap and water.

Interaction with other medicinal products and other forms of interaction

Interactions none preparation Benzyl benzoate are not described.

 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Although no studies on the effects on human pregnancy or lactation have been carried out, the drug is for topical use and is unlikely to represent a hazard to the pregnant or lactating patient.

Presumed to be safe and unlikely to produce an effect.

Benzyl benzoate is irritant to the eyes and mucous membranes and may be irritant to the skin. Hypersensitivity reactions have been reported. When ingested benzyl benzoate may cause stimulation of the CNS and convulsions. Systemic symptoms have been reported following excessive topical use.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Arpimed “LLC” by going to www.arpimed.com and fill out the appropriate form ″Report an adverse reaction or inefficiency of drug″. Hotline number: (+374 55) 05 79 86. And by using Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan ″CJSC ″, going to the site: www.pharm.am in ″Report about adverse effect of medicine″ section and fill out the ″Report of adverse reaction or manufacturing problem of medicinal product″. Hotline numbers: +37410200505; +37496220505.

Treatment of poisoning involves aspiration and lavage and appropriate symptomatic measures.

ATC code P03AX01. Other ectoparasiticides, incl. scabicides.

Benzyl benzoate is an acaricide, which eliminates Acarus scabiei, and is used in the treatment of scabies and pediculosis in man.

Absorbed benzyl benzoate is rapidly bio-transformed to hippuric acid, which is excreted in the urine.

No further information available.

 List of excipients

Stearic acid

Triethanolamine

Propylene glycol

Glycerin

Methylparaben

Propylparaben

Water purified

None known.

3 years.

After opening the bottle use till expiry date.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

• Store in original pack at a temperature not above 25ºC. Keep out of the reach of children.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measure will help protect the environment.
• You should avoid getting the emulsion on mucous membranes and eyes!
• Don’t freeze!
• Shake the bottle well before use!

120 ml 25% emulsion for topical use, is supplied in a amber glass bottle. (inside package)

The bottle is packed, labeled and inserted with the leaflet into cardboard box (outer package).

No special requirements.