PHYTODERM COMPOSITUM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENZOIC ACID; SALICYLIC ACID; TOLNAFTATE

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

D01AE12

Pharmaceutical form:

OINTMENT

Composition:

TOLNAFTATE 10 MG/G; BENZOIC ACID 60 MG/G; SALICYLIC ACID 30 MG/G

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

SALICYLIC ACID

Therapeutic area:

SALICYLIC ACID

Therapeutic indications:

Superficial dermatomycosis where a keratolytic effect is also required

Authorization date:

2011-04-30

Summary of Product characteristics

"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
לירפא
2011
.
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: April 2011.
PHYTODERM
® COMPOSITUM
OINTMENT
COMPOSITION
_Active Ingredient _
Tolnaftate
1%
Salicylic acid
3%
Benzoic acid
6%
_Other Ingredients _
Polyethylene
glycol
400, polyethylene
glycol
4000, white
vaseline,
butylated
hydroxytoluene.
MECHANISM OF ACTION
Phytoderm Compositum contains tolnaftate, a highly active synthetic
fungicidal agent
effective in the treatment of superficial fungal infections of the
skin. It is virtually non-
sensitizing, and does not ordinarily sting or irritate intact skin.
Phytoderm Compositum combines tolnaftate with the classic keratolytic
combination,
salicylic acid and benzoic acid, known as the Whitfield combination.
The Whitfield
combination has a dual role in Phytoderm Compositum – to remove the
thick keratin
layers which serve as substrate for fungus invasion and enhance the
penetration of
tolnaftate.
Phytoderm Compositum is therefore intended for the treatment of areas
of the skin
where the keratin layers are thick, as on the palms of the hands and
soles of the feet.
INDICATIONS
Superficial dermatomycoses where a keratolytic effect is also
required.
CONTRAINDICATIONS
Known hypersensitivity to any of the components of the preparation.
WARNINGS
For external use only.
In case of sensitization or irritation due to Phytoderm Compositum, or
if the patient’s
skin disease does not improve within 10 days or becomes worse during
self medication
with this product, treatment should be discontinued and the patient
should consult the
physician.
Phytoderm Compositum is not intended to be used in the eyes.
Phytoderm Compositum should be kept out of the reach of children.
Due to the salicylic acid component, this product should not be used
in the following
situations;
Patients presenting with diabetes mel