Benzyl benzoate emulsion for external use

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

benzyl benzoate

Dostopno od:

Arpimed LLC

Koda artikla:

P03AX01

INN (mednarodno ime):

benzyl benzoate

Odmerek:

250mg/ml

Farmacevtska oblika:

emulsion for external use

Enote v paketu:

120ml glass bottle

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2023-12-08

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
BENZYL BENZOATE
25% EMULSION FOR TOPICAL USE
1. NAME OF THE MEDICINAL PRODUCT – BENZYL BENZOATE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the emulsion contains benzyl benzoate 250 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for topical use.
A white emulsion with specific odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benzyl Benzoate is an acaricide used in the treatment of scabies and
pediculosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to benzyl benzoate or
any of the other ingredients of
this medicine listed in section 6.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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