Boots Antifungal 1% cream

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Prenos Navodilo za uporabo (PIL)
03-03-2023
Prenos Lastnosti izdelka (SPC)
09-02-2020

Aktivna sestavina:

Clotrimazole

Dostopno od:

The Boots Company Plc

Koda artikla:

D01AC01

INN (mednarodno ime):

Clotrimazole

Odmerek:

10mg/1gram

Farmacevtska oblika:

Cutaneous cream

Pot uporabe:

Cutaneous

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 13100200; GTIN: 5000167082425

Navodilo za uporabo

                                QUERIES FOR CLIENTS
ANY ‘CLIENT QUERY’ BOXES WILL BE VISIBLE IN
RED AND WILL BE AUTOMATICALLY REMOVED
ON APPROVAL OF THE ARTWORK.
APPROVAL BY THE ADMIN ‘MASTER’ APPROVER
WILL SIGNIFY THAT YOU ARE HAPPY TO
PROCEED TO PRINT WITHOUT ACTION BEING
TAKEN WITH REGARDS TO THE CLIENT QUERY.
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE
ALTERED WITHOUT PRIOR PERMISSION FROM WK360.
TECHNICAL INFORMATION, PRINTER PLEASE NOTE:
WK360 HAVE CREATED THIS ARTWORK TO A GENERIC PRINT
PROCESS SPECIFICATION AND REPRO HAS NOT BEEN APPLIED.
PLEASE CALL YOUR CLIENT CONTACT TO DISCUSS ANY AMENDS
OR IF ANYTHING FALLS BENEATH YOUR PRINT TOLERANCES
Applescan House, Latimer Road, Luton, Beds, LU1 3XE
TEL: 01582 487580 / 01582 456082 WEB: wk360.com
BRANDING
27/05/2021
DMC - Martyn Price
PRINTING COLOURS
PMS
285 C
PMS
280 C
Cutter
Guides
BRAILLE
TECHNICAL & NON-PRINTING
SPECIAL FINISHES & FOILS
5299
THIS SCALE MEASURES 50MM WHEN ARTWORK IS AT 100%
0
10
20
30
40
50
CATEGORY:
SYNERGIST JOB NO:
BRAND:
RANGE:
ITEM CODE:
BARCODE TYPE:
BARCODE NO.:
PROJECT NO.:
PRODUCT TITLE:
FILE NAME:
PROOF NUMBER:
PROOF DATE:
ARTWORKER:
PACK TYPE:
SUPPLIER CONTACT:
FINISH:
FINISH TYPE:
SUBSTRATE:
SUBSTRATE COLOUR:
SUPPLIER DETAILS:
PRINTER CONTACT:
PRINTER DETAILS:
NUMBER OF COLOURS:
BRAILLE:
Health
Boots Own Brand
Womens Health
6104924
EAN13
5000167082425
6
Gloss
Pattern
Carton Board
White
2
Yes
Teva
Helen.Sole@tevauk.com
WBA-1253-Antifungal Cream 20g Carton-6104924
PACK MOCK UP
ARTWORK TEXT SIZE
MAIN HEADINGS:
8pt
SUB HEADINGS:
7pt
BODY HEADINGS:
6.5pt
PACK DIMENSIONS
HEIGHT:
113mm
WIDTH:
37mm
DEPTH:
30mm
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
1
03/03/2021
Excipient warning
update
00289/1490
MHRA approved v1 13/01/2020
WBAG384905 B
Internally approved
20 g
Aluminium tube with
polypropylene screw on
cap containing 20 g of
cream.
Antifungal Cream
PRODUCT NAME:
PRODUCT LICENCE NO.:
WORDING REF:
STATUS:
PACK DETAILS:
PACK SIZE:
Artwork Only
GLOSS
VARNISH
READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
An antifungal cream for the t
                                
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Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lloydspharmacy Antifungal Skin Cream
Clotrimazole 1% w/w Cream
Boots Antifungal Cream
Tesco Antifungal Cream
Careway Antifungal 1% w/w Skin Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of skin infections due to dermatophytes (e.g.
trycophyton
species), yeasts (e.g. candida species), moulds and other fungi. These
include
ringworm (tinea) infections, paronychia, pityriasis versicolor,
erythrasma and
intertrigo,
as
well
as
fungal
nappy
rash,
candidal
vulvitis
and
candidal
balanitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Adult, children and elderly:
Apply to the affected area two or three times daily
Dermatophyte infections: treat for at least one month
Candida infections: treat for at least two weeks
Route of administration:
Directly applied to the affected area.
A physician should be consulted if symptoms do not improve within 7
days.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the components
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The cream contains cetyl alcohol and stearyl alcohol, which may cause
local
skin reaction (e.g. 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
Clotrimazole
Cream
may
cause
damage
to
latex
contraceptives.
Consequentially patients should be advised to use alternative
precautions for at
least five days after using this product.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Data on a large number of exposed pregnancies indicate no adverse
effects of
Clotrimazole on pregnancy or on the health of the foetus/newborn
child. To
date, no othe
                                
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