Benzyl Benzoate 25% w/v Application Cutaneous Emulsion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Benzyl benzoate

Verfügbar ab:

Ovelle Limited

ATC-Code:

P03AX; P03AX01

INN (Internationale Bezeichnung):

Benzyl benzoate

Dosierung:

25 percent weight/volume

Darreichungsform:

Cutaneous emulsion

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Other ectoparasiticides, incl. scabicides; benzyl benzoate

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1988-09-01

Gebrauchsinformation

BENZYL BENZOATE 25%W/V APPLICATION CUTANEOUS EMULSION
benzyl benzoate 25% w/v
PATIENT INFORMATION LEAFLET
_Read all of this leaflet carefully because it contains important
information for you. _
This medicine is available without a prescription. Nevertheless you
will still need to
use Benzyl Benzoate 25%w/v Application carefully to get the best
results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms do not improve after using
Benzyl Benzoate
25%w/v Application.
IN THIS LEAFLET
:
_1._
_ _
_What Benzyl Benzoate 25%w/v Application is and what it is used for _
_2._
_ _
_Before you use Benzyl Benzoate 25%w/v Application _
_3._
_ _
_How to use Benzyl Benzoate 25%w/v Application _
_4._
_ _
_Possible side effects _
_5._
_ _
_How to store Benzyl Benzoate 25%w/v Application _
_6._
_ _
_Further information _
1.
WHAT BENZYL BENZOATE 25%W/V APPLICATION IS AND WHAT IT IS
USED FOR
The name of your treatment is Benzyl Benzoate 25%w/v Application. It
is a smooth
white creamy emulsion. Benzyl Benzoate 25%w/v Application contains
benzyl
benzoate 25%w/v as the active ingredient. This application is used for
the treatment of
scabies and pediculosis (i.e. body or head lice).
SCABIES
is a persistent itchy skin eruption caused by cutaneous infestation
with
mites. The itch is worse after bathing and at night. Scabies affects
all races and social
classes world wide.
PEDICULOSIS
is a relatively common problem in school children in various parts
of the world. Females of all ages are more frequently infected than
males. There does
not appear to be any direct correlation between hair length and
infestation rates.
2.
BEFORE YOU USE BENZYL BENZOATE 25%W/V APPLICATION
_ _
_DO NOT USE BENZYL BENZOATE 25%W/V APPLICATION _

If you are allergic to benzyl benzoate or any of the other ingredients
of this
medicine listed in section 6.
_WARNINGS AND PRECAUTIONS _

Skin can become red and irritated at the site of application.
�

Fachinformation

Health Products Regulatory Authority
04 April 2019
CRN008NQZ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benzyl Benzoate 25% w/v Application Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Active Substance
​
%w/v
​
Benzyl Benzoate
​
25.0
Excipients
Constituents of emulsifying wax (Cetostearyl alcohol is present at
2.16 %
w
/
v
and E487 sodium laurilsulfate is present at 0.24 %
w
/
v
)
E218 Methyl Hydroxybenzoate is present at 0.165 % w/v
E214 Ethyl Hydroxybenzoate is present at 0.11% w/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion
Smooth white creamy emulsion.
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.
(A) 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 lotion 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.
(B) 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 persons hypersensitive to the active ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTION