Summary of Product Characteristics (SmPC) - Neo Baby cream
1 NAME OF THE MEDICINAL PRODUCT
Neo Baby Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide BP 0.2%
Benzalkonium Chloride 50% BP 0.1%
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment and prevention of rashes caused by chafing such as napkin rash.
4.2 Posology and method of administration
At each nappy change apply to the baby’s bottom after first washing and drying the skin.
4.3 Contraindications
Do not use the cream if the infant is known to be sensitive to any of the ingredients.
4.4 Special warnings and precautions for use
The cream contains a derivative of lanolin which may cause local skin reactions eg. contact dermatitis.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions recorded when used as directed.
4.6 Pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
None recorded
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, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The active agents are both Quaternary Ammonium compounds which are bactericidal agents. They help reduce bacterial breakdown of urea in the urine which is a major cause of napkin rash.
5.2 Pharmacokinetic properties
The active agents are held in solution and available for topical effect. The cream base also contains Silicone Oil which while not declared as an active does help form a surface barrier on the skin.
5.3 Preclinical safety data
None recorded.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetyl Alcohol,
Non Ionic Emulsifying Wax,
White Soft Paraffin,
Propyl Hydroxybenzoate,
Silicone Oil,
Poloxyethylene Lanolin Complex,
Perfume and Purified Water.
6.2 Incompatibilities
Quaternary Ammonium Compounds have their activity reduced by any residual soap left on the baby’s skin.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C.
Do not freeze.
6.5 Nature and contents of container
50g Aluminium Tube,
125g Polypropylene Tub.
6.6 Special precautions for disposal
No special instructions required.
7 MARKETING AUTHORISATION HOLDER
Neo Laboratories Ltd.
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02019/5002R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3 June 1987 / 23 September 1992
10 DATE OF REVISION OF THE TEXT
03/06/2019