Zeroneum
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zeroneum.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Soya bean oil, refined 83.35% w/w.
3 PHARMACEUTICAL FORM
Cutaneous Solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dry skin conditions including those associated with dermatitis and eczema.
4.2 Posology and method of administration
For cutaneous use.
The liquid should be added to the bath water.
For full bath (approx. 100 litres) - 20ml (1 measure).
For child’s bath (approx. 25 litres) - 5ml (1/4 measure).
For partial bath (approx. 5 litres) - 2.5ml (1/8 measure).
In particularly dry skin, 2-3 times the above quantities can be used.
Generally, 2-3 baths should be taken weekly. For babies and infants a daily bath is recommended.
4.3 Contraindications
Known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
This product contains soya oil and should not be used by patients who are allergic to peanut or soya.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
Not known.
4.7 Effects on ability to drive and use machines
Not applicable.
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 professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9
Overdose
Not applicable.
5.1 Pharmacodynamic properties
Zeroneum was developed in response to the need for a suitable non-irritant cleansing agent for patients with eczema. As the skin in this condition requires the application of large amounts of fat, cleansing properties as well as greasing properties were combined. Zeroneum contains a plant oil having a high proportion of unsaturated fatty acid (linoleic acid up to 60%). The emulsifier used is a mixture of fatty acid amides with aliphatic alcohol and readily dispersible macrogol lauryl ester. Butylated hydroxytoluene is added as an antioxidant.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol lauryl ether (Laureth-4)
Comperlan (oleic acid diethanolamide)
Butylated hydroxytoluene (E321)
Propylene glycol
Perfume (Balneum A167139).
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Container: HDPE bottle with polypropylene cap containing 500ml of solution.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Zeroderma Ltd
Linthwaite Laboratories
Linthwaite
Huddersfield
HD75QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 18962/0004.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/08/2008
10 DATE OF REVISION OF THE TEXT
23/12/2014