Sudocrem Antiseptic Healing Cream

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Benzyl alcohol; Benzyl cinnamate; Benzyl benzoate; Wool fat; Zinc oxide

Mevcut itibaren:

Norton Waterford

ATC kodu:

D02AB

INN (International Adı):

Benzyl alcohol; Benzyl cinnamate; Benzyl benzoate; Wool fat; Zinc oxide

Farmasötik formu:

Cream

Terapötik alanı:

Zinc products

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1978-04-01

Ürün özellikleri

Health Products Regulatory Authority
17 July 2023
CRN00DGW4
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sudocrem Antiseptic Healing Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
% w/w
Zinc Oxide
15.29
Benzyl alcohol
0.39
Benzyl benzoate
1.02
Benzyl cinnamate
0.15
Wool Fat (Lanolin (hypoallergenic)
4.02
Excipients with known effect:
0.48% w/w Sodium Benzoate (E211), 0.33% w/w Propylene glycol (E1520)
and 0.01% w/w Butylated hydroxyanisole (E320).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth, homogeneous, white, water in oil cream with a lavender
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sudocrem Antiseptic Healing Cream is indicated in the management of
various dermatoses, including local skin reactions
associated with incontinence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply a thin layer with suitable covering where necessary. Renew
application as required. No distinction is required between
indications or for adults, children and the elderly.
Method of administration
Topical cream for external use only.
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
For external use only and should not be allowed to come into contact
with the eyes and the mucous membranes.
If there is no improvement in the condition or aggravation thereof,
the doctor should be consulted.
Excipient(s)
Sodium benzoate may cause non-immunologic immediate contact reactions
by a possible cholinergic mechanism. Absorption
through the immature skin of neonates is significant and may increase
jaundice in this population.
Butylated hydroxyanisole may cause local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and mucous
membranes.
Propylene glycol may cause skin irritation. This medicine should not
be used in babies less than 4 weeks old with open wounds
or large areas of broken or damaged skin (such as burns).
Health