DENTI-CARE DENTI-RINSE CHLORHEXIDINE GLUCONATE ORAL RINSE- chlorhexidine gluconante liquid

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
12-10-2020

Aktiv ingrediens:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Tilgjengelig fra:

Xttrium Laboratories, Inc.

Administreringsrute:

DENTAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

INDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS. CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Produkt oppsummering:

HOW SUPPLIED: Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures, NDC 64778-0244-1. Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                DENTI-CARE DENTI-RINSE CHLORHEXIDINE GLUCONATE ORAL RINSE-
CHLORHEXIDINE
GLUCONANTE LIQUID
XTTRIUM LABORATORIES, INC.
----------
DENTI-CARE DENTI-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE MINT
_DENTI-CARE_
MEDICOM
DENTI-RINSE
0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE
MINT
Item 10025-H
Ingredients: 0.12 % chlorhexidine gluconate in a base containing
water, 11.6 % alcohol, glycerin, PEG-
40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue
No.1.
RX ONLY
KEEP OUT OF REACH OF CHILDREN
1 Pint (473 ml)
NDC 64778-0244-1
M0701707V.2
DIRECTIONS FOR USE: Fill cap to the “fill line” (15 mL). Swish in
mouth undiluted for 30 seconds,
then spit out. Use after breakfast and before bedtime. Or, use as
prescribed. NOTE: To minimize
medicinal taste, do not rinse with water immediately after use.
To open: Squeeze smooth areas near bottom of cap and turn.
To close: Turn Cap until it locks.
WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your
dentist has prescribed chlorhexidine gluconate oral rinse to treat
your gingivitis, to help reduce the
redness and swelling of your gums, and also to help you control any
gum bleeding. Use chlorhexidine
gluconate oral rinse regularly, as directed by your dentist, in
addition to daily brushing. Spit out after
use; Chlorhexidine gluconate oral rinse should not be swallowed.
Chlorhexidine gluconate oral rinse
may cause some tooth discoloration, or increase in tartar (calculus)
formation, particularly in areas
where stain and tartar usually form. It is important to see your
dentist for removal of any stain or tartar at
least every six months or more frequently if your dentist advises. •
Both stain and tartar can be removed
by your dentist or hygienist. Chlorhexidine gluconate oral rinse may
cause permanent discoloration of
some front-tooth fillings. • To minimize discoloration, you should
brush and floss daily, emphasizing
areas which begin to discolor. • Local hypersensitivity and
sometimes generalized allergic reactions
have also been reported. Chlorhe
                                
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