Boots Mouth Ulcer gel

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Cetylpyridinium chloride; Lidocaine

متاح من:

The Boots Company Plc

ATC رمز:

N01BB52

INN (الاسم الدولي):

Cetylpyridinium chloride; Lidocaine

جرعة:

200microgram/1gram ; 6mg/1gram

الشكل الصيدلاني:

Oromucosal gel

طريقة التعاطي:

Oromucosal; Gingival

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 12030100; GTIN: 5045097801005

نشرة المعلومات

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: [phone] WEB: wk360.com
BRANDING
SUPPLIER CONTACT:
SUPPLIER DETAILS:
PRINTER CONTACT:
PRINTER DETAILS:
20/01/2023
PRINTING COLOURS
PMS
2985 C
PMS
287 C
PMS
1795 C
Cutter
Guides
BLACK
BRAILLE
TECHNICAL & NON-PRINTING
SPECIAL FINISHES & FOILS
5977
THIS SCALE MEASURES 50MM WHEN ARTWORK IS AT 100%
0
10
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50
CATEGORY:
SYNERGIST JOB NO:
BRAND:
RANGE:
PROJECT NO.:
PRODUCT TITLE:
FILE NAME:
PROOF NUMBER:
PROOF DATE:
ARTWORKER:
PACK TYPE:
FINISH:
FINISH TYPE:
SUBSTRATE:
SUBSTRATE COLOUR:
NUMBER OF COLOURS:
BRAILLE:
Health
Boots Own Brand
Mouthcare & Earcare
22-73-950
EAN13
NWJN8
5000167077025
Boots Mouth Ulcer Gel 15g - Carton
6
Gloss
Carton
Pattern
Carton Board
White
4
Yes
WBA-3291-Boots Mouth Ulcer Gel 15g - Carton-2273950
PACK MOCK UP
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
1
16/01/2023
Updated for
methaemoglobinemia
warning to align with
CCDS
PL 00014/0150
MHRA Approved
WBA-3291-R3 13-01-2023
Internally approved
15 g
Mouth Ulcer Gel
PRODUCT NAME:
PRODUCT LICENCE NO.:
WORDING REF:
STATUS:
PACK DETAILS:
PACK SIZE:
Internally lacquered aluminium tube
(polyamide/polyimide lacquer system) with
a membrane seal fitted with a wadless polyethylene
cap or a polypropylene cap.
Artwork Only
ITEM CODE:
BARCODE TYPE:
BARCODE NO.:
COMPONENT CODE:
PHARMA CODE NO.:
GLOSS
VARNISH
ARTWORK
22-73-950
LOT/USE BY:
If you need more
advice ask your
pharmacist.
READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS.
WHAT THIS MEDICINE IS FOR
An antiseptic gel for the rapid relief of common mouth
ulcer pain.
BEFORE YOU USE THIS MEDICINE
B
DO NOT USE:
• IF YOU ARE ALLERGIC to any of the ingredients
• If you have methaemoglobinae

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sore Mouth Gel or Boots Mouth Ulcer Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Quantity
Lidocaine base
0.6 % w/w
Cetylpyridinium chloride
0.02 % w/w
Excipients of known effect
ethanol (alcohol 96%)
35.00 % v/w
sucrose (refined sugar)
5 % w/w
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oromucosal Gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the rapid relief of pain caused by minor recurrent aphthous mouth
ulcers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical application to the mouth and gums.
Adults and children aged 5 months and over
A small quantity of gel to be applied to the sore area with a clean
finger every
three hours as necessary.
Babies under 5 months
Not suitable.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredients or to any of the excipients
listed in
section 6.1)
Current or past history of methaemoglobinaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines out of the reach of children.
If symptoms persist for more than seven days consult your doctor or
dentist.
Not suitable for treatment of teething in children.
This medicine contains 350 mg of alcohol (ethanol) in each 1g of gel.
The
amount in 0.2g of this medicine is equivalent to less than 1.6 ml beer
or 1.1 ml
wine. The small amount of alcohol in this medicine will not have any
noticeable effects.
Patients with rare hereditary problems of fructose intolerance,
glucose-
galactose malabsorption or sucrase-isomaltase insufficiency should not
take
this medicine.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically significant drug interactions known.
4.6
PREGNANCY AND LACTATION
The safety of this product during pregnancy and lactation has not been
established. The product is, therefore, not recommended during
pregnancy and
lactation except under medical supervision.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No adverse effects known.
4.8
UNDESI