Chlorhexidine gluconate 0.2% mouthwash peppermint

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Chlorhexidine gluconate

Disponible depuis:

Thornton & Ross Ltd

Code ATC:

A01AB03

DCI (Dénomination commune internationale):

Chlorhexidine gluconate

Dosage:

2mg/1ml

forme pharmaceutique:

Mouthwash

Mode d'administration:

Oromucosal

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 12030400; GTIN: 5011309014310

Notice patient

_Data Matrix:_
_ _
23053506 VERIFIED
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
561598
11985
Addition of 'Peppermint Flavour'
at request of Marketing
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Landscape peelable label
300ml
23053506
65 x 170mm
1
10.03.2015
Process Cyan
Process Magenta
Process Yellow
Process Black
Keyline (Does not print)
Braille
Text free area (Does not print)
Care Chlorhexidine Digluconate 0.2%
w/v Antiseptic Mouthwash
Helvetica
Helvetica Neue LT
Optima BQ
TREATS & PREVENTS GUM DISEASE
_CARE_
_CHLORHEXIDINE_
_DIGLUCONATE 0.2% W/V _
_ANTISEPTIC MOUTHWASH_
_PEPPERMINT FLAVOUR_
PEEL
HERE
300ML
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
For the treatment and prevention of gingivitis
(gum disease), gum ulceration, oral thrush,
denture sores and for maintaining oral
hygiene.
Use the solution only in the mouth. Do not
swallow.
ADULTS, THE ELDERLY AND CHILDREN:
• Measure 10ml in the cup provided.
• Rinse the mouth thoroughly for about
1 minute, then spit out.
• Use twice a day.
GINGIVITIS (GUM DISEASE): Use as above for
one month.
MOUTH ULCERS AND THRUSH: Use as above,
continuing for 2 days after symptoms go.
DENTURE SORES: Use as above, also soak
dentures for 15 minutes, twice a day.
If symptoms persist, stop use and
consult your doctor or dentist.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT: chlorhexidine digluconate
0.2% w/v.
ALSO CONTAINS: ethanol, castor oil polyoxyl
hydrogenated, menthol, peppermint oil,
aspartame (E951) and purified water.
Alcohol 7 vol%.
Do not store above 25°C. Once opened use
within 28 days.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder Thornton
and Ross Ltd., Huddersfield, HD7 5QH, UK.
PL 00240/0118 PIP: 300-7994
23053506
This mouthwash contains chlorhexidine digluconate,
a disinfectant and antisepti

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash
Peppermint Flavour
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine
Digluconate
0.2%
w/v
(equivalent
to
Chlorhexidine
Gluconate
Solution 1.0% v/v)
For excipients see 6.1
3
PHARMACEUTICAL FORM
Mouth wash.
A clear, colourless liquid with an odour of menthol and peppermint.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aids prevention of dental plaque formation. Aids the treatment and
prevention of
gingivitis. For the maintenance of oral hygiene. Promotes gingival
healing following
periodontal surgery. Management of recurrent oral ulceration. For the
treatment of
denture stomatitis and oral thrush.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oromucosal use.
Adults, the elderly and children: To be used as required up to twice
daily. Rinse the
mouth thoroughly for about 1 minute with 10ml. The mouthwash should be
expelled
from the mouth after rinsing.
Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1
minute. The
mouthwash should be expelled from the mouth after rinsing.
Treatment of gingivitis: A course of one month is recommended.
Treatment of denture stomatitis: Soak the denture(s) in solution for
15 minutes twice
daily.
Treatment of oral ulceration and oral thrush: Treatment should be
continued for 48
hours after clinical resolution.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the product or any of its components,
especially in those with a
history of possible chlorhexidine-related allergic reactions (see
sections 4.4 and 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For oral use only. Keep away from the eyes and ears. If the solution
comes into contact with
the eyes, rinse well with water. Keep out of the reach and sight of
children. Do not swallow.
If symptoms persist, stop using and consult your doctor or dentist.
Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known
to induce
hypersensitivity, including generalised allergic rea