INOTYOL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENZOIN SIAM; HAMAMELIS; ICHTHAMMOL; TITANIUM DIOXIDE; ZINC OXIDE

Available from:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

Pharmaceutical form:

OINTMENT

Composition:

ICHTHAMMOL 1.474 G / 100 G; ZINC OXIDE 14.763 G / 100 G; HAMAMELIS 0.984 G / 100 G; BENZOIN SIAM 0.1 G / 100 G; TITANIUM DIOXIDE 5.905 G / 100 G

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

LABORATOIRES URGO HEALTHCARE, FRANCE

Therapeutic indications:

Local treatment of eczema, feet ulcers, mild burns and skin irritations.

Authorization date:

2014-01-19

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This product can be sold without a doctor’s prescription
INOTYOL OINTMENT
Each 100 grams )g( of ointment contain:
Zinc oxide 14.763 g.
Titanium dioxide 5.905 g.
Ichthammol 1.474 g.
Hamamelis extract 0.984 g.
Siam benzoin 0.1 g.
Inactive ingredients and allergens in the product - see section 2
"
Important information about some of the ingredients of this
product
"
and section 6 in the leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
PRODUCT. This leaflet contains concise information about the
product. If you have any further questions, ask the doctor or
pharmacist.
Use this product according to the instructions in the dosage
section of this leaflet. Consult the pharmacist if you need
additional information. Refer to the doctor if the symptoms of
the illness worsen or do not improve after a few days.
1. WHAT IS THE PRODUCT INTENDED FOR?
For local treatment of eczema, foot ulcers, mild burns and
skin irritations such as: skin redness in infants )diaper rash(,
chilblains.
THERAPEUTIC GROUP – ointment for treatment of skin irritations,
sores and skin ulcers.
2. BEFORE USING THE PRODUCT
DO NOT USE THE PRODUCT IF:
• you are hypersensitive )allergic( to the active ingredients )see
above( or to any of the other ingredients this product contains
)see section 6
"
Additional information
"
).
• you
suffer
from
dermatitis
accompanied
by
secretions
or
infection.
• your child has suffered in the past from convulsions, related
to fever or other causes )as the product contains terpene
derivatives(.
SPECIAL WARNINGS REGARDING THE USE OF THIS PRODUCT
• This product contains terpene derivatives which may )when used
in high doses( cause neurological events such as: convulsions in
infants and children.
• Do not apply a higher dosage than recommended )see section 3
"
How to use this product
"
).
• Do
not
apply
over
a
large
area
of
the
skin.
Follow
the
recommended instructions for use
• The product conta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
INOTYOL, OINTMENT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ichthammol..................................................................................................................
1.474 g
Zinc
oxide..................................................................................................................
14.763 g
Hamamelis..................................................................................................................
0.984 g
Siam
benzoin..............................................................................................................
0.100 g
Titanium
dioxide..........................................................................................................
5.905 g
For 100 g of ointment.
Excipients with recognised effect: lanolin, terpene derivatives,
alcohol.
For a full list of the excipients, see sections 6.1.
3.
PHARMACEUTICAL FORM
Ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Local treatment of eczema, feet ulcers, mild burns and skin
irritations.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Apply as a thick layer 2 or 3 times daily.
4.3.
CONTRAINDICATIONS
•
Known hypersensitivity to any of the ingredients,
•
Infected or weeping dermatitis,
•
children with a history of convulsions, febrile or otherwise (due to
the presence of terpene derivatives as
excipients).
4.4.
SPECIAL WARNINGS AND PRECAUTION FOR USE
SPECIAL WARNINGS
This medicine contains terpene derivatives as excipients, which can
lower the seizure threshold. At excessive
doses, risk of neurological accidents such as convulsions in infants
and children.
Follow the doses and the recommendations for use. In particular, do
not apply to a large surface area of the
body.
This medicine contains alcohol.
This medicine contains 0.15 g of alcohol per 50 g tube.
Alcohol is a substance with a risk of percutaneous toxicity,
particularly in neonates (born prematurely or at full-
term). Exposure of immature skin (especially under