Zerocream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zerocream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid paraffin 12.6% w/w.
Soft white paraffin 14.5% w/w.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
Zerocream is a smooth white opaque cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Zerocream is an emollient used for the symptomatic treatment of flaking, dry or chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.
4.2 Posology and method of administration
For cutaneous application.
Adults, Children and Elderly:
The cream should be applied to the dry skin areas two or three times daily and rubbed well into the skin.
Contraindications
4.3
There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
If this product comes into contact with dressings and clothes, it can be easily ignited with a naked flame. Patients are advised to avoid fire when using ZeroCream.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No restrictions on the use of the product in pregnancy and lactation are proposed.
4.7 Effects on ability to drive and use machines
None known.
4.8. Undesirable Effects
Rarely mild skin reactions have been observed which may take the form of an allergic rash. Should this occur the use of the product should be discontinued.
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
The cream is of low toxicity. Conservative treatment only is required should accidental ingestion occur.
5.1 Pharmacodynamic properties
ATC Code: DO2A. Emollients and Protectives
The active ingredients in Zerocream are liquid paraffin and soft white paraffin which have emollient properties which provides a moisturising action on dry or chapped skin.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the consumer which are additional to that already included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lanolin anhydrous Glyceryl monostearate Cetyl alcohol
Sodium cetostearyl sulphate Citric acid (monohydrate) (E330)
Carbomer (carbopol 974P)
Purified water
Sodium hydroxide (10% w/v solution) 2-phenoxyethanol containing NIPA esters (phenonip) Phenonip is comprised of:-Methyl hydroxybenzoate (E218)
Ethyl hydroxybenzoate (E214)
Propyl hydroxybenzoate (E216)
Butyl and isobutyl hydroxybenzoate
6.2
Incompatibilities
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
500 gram polypropylene jar with LDPE ‘screw cap’ closure.
50 gram and 100 gram LDPE tube with LDPE flip-top closure. Not all pack sizes may be marketed
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Zeroderma Ltd Linthwaite Huddersfield West Yorkshire HD75QH
8 MARKETING AUTHORISATION NUMBER(S)
PL 18962/0006.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/07/2005. 22/02/2010
10 DATE OF REVISION OF THE TEXT
23/12/2014