Zeroguent
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zeroguent.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light liquid paraffin 8.0% w/w.
White soft paraffin 4.0% w/w.
Soya bean oil (refined and deodorised) 5.0% w/w.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Zeroguent is a smooth white opaque cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Zeroguent is used as a diluent for various topical corticosteroid formulations in those instances where a lower strength preparation is considered desirable by the physician and as a general base for extemporaneous dispensing.
Zeroguent is an emollient used for the symptomatic treatment of dermatitis, ichthyosis, eczema, nappy rash, protection of raw and abraded skin areas, pruritis and related skin conditions where dry scaly skin is a problem and as a pre-bathing emollient for dry/eczematous skin, to alleviate drying effects.
4.2. Posology and Method of Administration
For cutaneous application.
Adults, Children and Elderly:
A thin application of the cream should be gently massaged into the skin three times daily or at appropriate intervals. When used as a protective cream,
Zeroguent should be applied sparingly to the affected areas of the skin before or immediately after, exposure to a potentially harmful factor.
4.3. Contra-indications
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
This product contains soya oil. If you are allergic to peanut or soya, do not use this product.
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 Zeroguent Cream.
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. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
ATC Code: DO2A C. Emollients and Protectives
The active ingredients in Zeroguent are light liquid paraffin, soft white paraffin and soya bean oil all have emollient properties which maintain the high lipid content of an ointment and also has the water miscible characteristics of a cream. The high lipid content reduces water loss from the skin and therefore has a hydrating effect which aids the recovery from dermatitis, eczema and dry or scaly skin conditions. Zeroguent also contains sorbic acid which has an antibacterial effect.
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 Excipient(s)
Glyceryl monostearate 40-55 Cetostearyl alcohol Propylene glycol Colloidal anhydrous silica Sorbic acid (E200)
Polysorbate 40 (E434)
Purified water
Hydrochloric acid
6.2. Incompatibilities
None known.
6.3. Shelf Life
24 months.
Six months after opening.
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 closure.
6.6. Instruction for Use/Handling and Disposal
None.
7 MARKETING AUTHORISATION HOLDER
Zeroderma Ltd
Linthwaite Laboratories
Linthwaite
Huddersfield
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 18962/0007.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/02/2010
10 DATE OF REVISION OF THE TEXT
23/12/2014