Whitfield's Antifungal 3% w/w & 6% w/w Ointment

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Salicylic acid; Benzoic acid

Disponível em:

Ovelle Limited

Código ATC:

D01AE; D01AE12

DCI (Denominação Comum Internacional):

Salicylic acid; Benzoic acid

Dosagem:

3 %w/w + 6 percent weight/weight

Forma farmacêutica:

Ointment

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Other antifungals for topical use; salicylic acid

Status de autorização:

Marketed

Data de autorização:

1991-06-10

Características técnicas

Health Products Regulatory Authority
07 February 2022
CRN009MT1
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Whitfield's Antifungal 3% w/w & 6% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoic Acid 6% w/w and Salicylic Acid 3% w/w.
Excipient: Emulsifying Wax contains 21.84 w/w Cetostearyl alcohol and
5.46 % w/w Sodium laurilsulfate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Smooth, white opaque ointment with a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Whitfield’s Antifungal 3% w/w & 6% w/w Ointment is recommended for
the topical treatment of fungal infections of the skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Whitfield’s Antifungal 3% w/w & 6% w/w Ointment is applied topically
and is for external use only.
Wash the skin with water and soap. Apply the ointment twice daily in a
thin layer to the affected parts of the skin only.
Treatment may take several weeks.
ADULTS: Apply topically to the affected to the affected area twice
daily. No more than 3 fingertip units should be applied at any
one time unless directed to do so by a doctor. One fingertip unit
should be enough to cover twice the area of an adult hand.
CHILDREN UNDER 16 YEARS OF AGE: Do not use on children under 16 years
of age unless directed to do so by your doctor.
CHILDREN BETWEEN 16 AND 18 YEARS OF AGE: Apply no more than two
fingertip unit to the affected area twice a day. Do not
exceed this dose unless directed to do so by your doctor.
4.3 CONTRAINDICATIONS
Whitfield’s Antifungal 3% w/w & 6% w/w Ointment is contraindicated
in patients with a known sensitivity to Benzoic Acid or
Salicylic Acid.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Whitfield's Antifungal 3% w/w & 6% w/w Ointment should not be used on
skin affected by psoriasis or eczema. Cetostearyl
alcohol may cause local skin reactions (e.g. contact dermatitis).
The thickness of the skin varies considerably according to the body
site and with age and can be an