Ovelle Aqueous Cream Tube 250ml

Aqueous Cream
Emulsifying Wax 9% w/w, White Soft Parafin 15% w/w, Liquid Paraffin 6% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsifying Wax BP 9.0%w/w
White Soft Paraffin BP 15.0%w/w
Liquid Paraffin Ph. Eur. 6.0%w/w
Excipient: contains 7.8% w/w Cetostearyl alcohol and 1.2% w/w Sodium lauril sulfate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth white homogenous, light cream with a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
a) Moisturiser and emollient that soothes and helps to hydrate dry skin.
b) Soap substitute.
Eczema and other dry skin conditions.
4.2 Posology and method of administration
Apply as often as required to prevent itching and flaking dry skin.
Adults: as above
Babies: as above
Elderly: as above
4.3 Contraindications
Not to be used by persons known to be sensitive to the ingredients.
4.4 Special warnings and precautions for use
For external use only.
If there is no improvement or aggravation of the conditions occurs, consult your doctor. Contains sodium laurilsulfate
and Cetostearyl alcohol which may cause local skin reactions (e.g. stinging and contact dermatitis).
Paediatric population
Aqueous cream contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact
dermatitis), particularly in children with atopic eczema.
Health Products Regulatory Authority
Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding,
the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away
from fire when using this product.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
Aqueous Cream is a monograph of the BP 1993 and as such
a) No animal reproduction/fertility study was carried out.
b) No study was carried out.
c) No known reason for not using in fertile, pregnant or lactating women.
4.7 Effects on ability to drive and use machines
1. Presumed to be safe and unlikely to produce an effect.
2. N/A.
3. N/A.
4.8 Undesirable effects
Allergic reaction to phenoxyethanol, which is rarely experienced.
Occasional allergic reactions. Aqueous cream may be associated with immediate cutaneous reactions when used as a
leave-on emollient, such as stinging, burning, itching and redness. See section 4.4.
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 professionals are asked to report any
suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: [email protected].
4.9 Overdose
N/A.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D02AX Other emollients and protectives
- Emollient.
- The fats and oils in Aqueous Cream BP form a layer on the skin to help prevent moisture loss through the skin.
Health Products Regulatory Authority
5.2 Pharmacokinetic properties
a) General
- absorption N/A
- distribution N/A
- biotransformation N/A
- elimination N/A
b) Characteristics in Patients
- Not applicable.
5.3 Preclinical safety data
Monograph of the BP 1993 and historically in many editions.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Phenoxyethanol
Purified water
6.2 Incompatibilities
Since Aqueous Cream contains an anionic surfactant it should not be used to dilute steroid creams or ointments.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25oC.
Keep container tightly closed.
6.5 Nature and contents of container
White polypropylene jar with white polypropylene lid containing 100g of cream.
White polypropylene jar with white polyethylene lid containing 500g of cream.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from
such medicinal product and other handling of the product
No special requirements.
Health Products Regulatory Authority
7 MARKETING AUTHORISATION HOLDER
Ovelle Ltd.
Industrial Estate
Coe’s Rd
Dundalk
Co. Louth
Ireland
8 MARKETING AUTHORISATION NUMBER
PA0206/021/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18th November 1988
Date of last renewal: 18th November 2008
10 DATE OF REVISION OF THE TEXT
October 2017