Boots Antiseptic Nappy Rash cream

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Dimeticone; Cetrimide

Disponibbli minn:

The Boots Company Plc

Kodiċi ATC:

n/a

INN (Isem Internazzjonali):

Dimeticone; Cetrimide

Dożaġġ:

100mg/1gram ; 5mg/1gram

Għamla farmaċewtika:

Cutaneous cream

Rotta amministrattiva:

Cutaneous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 13020200; GTIN: 5045092459102

Fuljett ta 'informazzjoni

PL 00014/5260R - A4 wording label-leaflet
PL00014/5260R
CHILDREN’S NAPPY RASH CREAM
INFANT NAPPY RASH CREAM
BOOTS ANTISEPTIC NAPPY RASH CREAM
The above products are not currently marketed, hence A4 text version
of the label-
leaflet wording is provided
PL 00014/5260R - A4 wording label-leaflet
FRONT OF PACK LABEL
CHILDREN'S NAPPY RASH CREAM
INFANT NAPPY RASH CREAM
BOOTS ANTISEPTIC NAPPY RASH CREAM
CETRIMIDE
DIMETICONE
FOR THE TREATMENT AND PREVENTION OF NAPPY RASH
NEW SAFETY INFORMATION – SEE LABEL
BACK OF PACK LABEL-LEAFLET
READ ALL OF THIS LABEL FOR FULL INSTRUCTIONS.
USES: A soothing and antiseptic cream for the prevention and treatment
of nappy rash.
BEFORE YOU USE THIS MEDICINE
X DO NOT USE:

IF YOUR CHILD IS ALLERGIC to any of the ingredients

IF THE SKIN is weeping or badly swollen
Cetostearyl alcohol and chlorocresol may cause skin reactions (e.g.
contact dermatitis or
allergic reactions such as skin rash, red or itchy skin).
INFORMATION FOR ADULTS INTENDING TO USE THIS CREAM: All of the
information on the label
applies to you as well. Talk to your pharmacist or doctor if you are
pregnant of breastfeeding.
 HOW TO USE THIS MEDICINE
Check the tub seal is not broken before first use.
Avoid contact with the eyes.
Apply this cream at each nappy change after cleaning and drying the
nappy area. Apply a
thin layer evenly across the nappy area then gently rub in.
For use on the skin only.
If accidentally swallowed: This cream may cause stomach discomfort or
diarrhoea. If
concerned talk to a pharmacist or doctor.
! Do not 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.
POSSIBLE SIDE EFFECTS
Most people will not have problems, but some may get some of these:

Skin rash, skin irritation, burning sensation or red itchy skin (signs
of an allergic reaction)
REPORTING OF SIDE EFFECTS
I

Karatteristiċi tal-prodott

SUMMARY 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
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
There are no clinically significant interactions
4.6
FERTILITY, PREGNANCY AND LACTATION
The safety of this product 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.
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 Yell