Desenex Ointment Zinc Undecylenate 20% w/w Undecylenic Acid 5% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc undecylenate; Undecylenic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

D01AE; D01AE04

INN (International Name):

Zinc undecylenate; Undecylenic acid

Dosage:

20/5 percent weight/weight

Pharmaceutical form:

Ointment

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antifungals for topical use; undecylenic acid

Authorization status:

Marketed

Authorization date:

1998-03-20

Summary of Product characteristics

Health Products Regulatory Authority
26 June 2020
CRN009671
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desenex Ointment Zinc Undecylenate 20% w/w Undecylenic Acid 5% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Undecylenate 20.0 % w/w
Undecylenic Acid 5.0 % w/w
Excipients with known effect
Contains wool fat 3.0 % w/w, methyl parahydroxybenzoate (E218) 0.3 %
w/w, propyl parahydroxybenzoate (E216) 0.075 % w/w
and benzyl benzoate (Max 0.25% w/w).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A white to cream coloured smooth ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desenex is recommended in the prophylaxis and treatment of mycotic
superficial dermatophytoses of feet and the relief of
itching and scaling produced by these fungal infections. Is it also
used to remove foot odour and prevent sweating.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
For topical administration only.
_General directions_:
Apply a smooth even coating of ointment to affected areas as required
or use as directed by the physician
_Feet:_
Twice daily, wash and dry the infected area, apply ½ inch (12.7 mm)
ribbon of ointment and rub gently between toes and on
feet. Spread evenly.
Continue treatment for two weeks after symptoms disappear. If there is
no improvement after 2 weeks treatment or symptoms
worsen consult your doctor or pharmacist.
To prevent reinfection, use Desenex Powder daily.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not recommended for nail or scalp infections.
Do not use on children under 2 years of age, except under the advice
and supervision of a doctor.
Health Products Regulatory Authority
26 June 2020
CRN009671
Page 2 of 5
If there is no response within 2 weeks, or the condition is
aggravated, use of the product should be stopped and the physician
should be consulted.
Desenex ointment contains methyl parahydrox