Caldease 15% w/w Medicated Ointment

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Zinc oxide

Fáanlegur frá:

Clonmel Healthcare Ltd

ATC númer:

D02AB

INN (Alþjóðlegt nafn):

Zinc oxide

Skammtar:

15 percent weight/weight

Lyfjaform:

Ointment

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Zinc products

Leyfisstaða:

Marketed

Leyfisdagur:

1985-01-08

Vara einkenni

Health Products Regulatory Authority
15 November 2019
CRN008JXK
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caldease 15% w/w Medicated Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc oxide 15% w/w.
Excipients with known effect
Methylhydroxybenzoate 0.40 % w/w, Propylhydroxybenzoate 0.10 % w/w,
Lanolin oil 5.00 % w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A grey-white ointment with characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Caldease Ointment promotes the healing of nappy rash. Protects
irritated skin and smoothes minor skin irritations, superficial
wounds and burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply each time after area has been cleansed and dried.
_Nappy rash_
To help prevent nappy rash, apply a smooth even coating of ointment at
each nappy change.
There is no recommended dose schedule.
Method of administration
For topical administration only.
4.3 CONTRAINDICATIONS
1. Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
2. Use in the treatment of fungal infections.
3. Use on large surface wounds and major burns.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is no improvement, or there is aggravation of the condition,
consult the doctor.
Contains parahydroxybenzoates which may cause allergic reactions
(possibly delayed).
Contains lanolin oil which may cause local skin reactions (e.g.,
contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Health Products Regulatory Authority
15 November 2019
CRN008JXK
Page 2 of 3
None.
4.6 FERTILITY, PREGNANCY AND LACTATION
None.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
None.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professional