Childrens Nappy Rash Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Children’s Nappy Rash Cream or Infant Nappy Rash Cream Boots Antiseptic Nappy Rash Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients %w/w
Cetrimide Ph Eur 0.5
Dimethicone 20 Ph Eur 10.0
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment and prevention of nappy rash.
For topical application to the skin.
Use during each nappy change.
Clean and thoroughly towel dry the nappy area.
Spread the cream lightly and evenly over the whole nappy area and then rub gently into the skin.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Do not use if the skin is weeping or badly inflamed. Avoid contact with the eyes.
For external use only.
Keep all medicines out of the reach of children
4.5 Interaction with other medicinal products and other forms of interaction
There are no clinically significant interactions
The safety of Children’s Nappy Rash Cream during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Skin irritation may occasionally occur and hypersensitivity reactions may develop in certain individuals.
4.9 Overdose
It is unlikely that systemic toxicity will result from the ingestion of Children’s Nappy Rash Cream although it may give rise to gastrointestinal irritation and possibly laxation
Treatment should be symptomatic.
5.1 Pharmacodynamic properties
Dimethicone 20 is water repellent and will protect the skin against water soluble irritants. Cetrimide is a quaternary ammonium disinfectant having bactericidal activity against both gram-positive and gram-negative organisms.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorocresol Liquid paraffin Cetostearyl alcohol Zinc oxide
Perfume compound DROM 442996 Purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store below 250C.
6.5 Nature and contents of container
A polypropylene tub fitted with a polypropylene cap or a green or white polyethylene cap.
Pack size: 125gm or 300gm
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/5260R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25 July 1989 / 24 January 1995
10 DATE OF REVISION OF THE TEXT
22/08/2006