NUPRO 60 SECOND FLUORIDE FOAM- sodium fluoride aerosol, foam

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

הורד מאפייני מוצר (SPC)
07-11-2022

מרכיב פעיל:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

זמין מ:

Dentsply Professional

INN (שם בינלאומי):

SODIUM FLUORIDE

הרכב:

FLUORIDE ION 27.3 mg in 1 g

מסלול נתינה (של תרופות):

DENTAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

For topical application to aid in the protection against dental caries. Hypersensitivity to fluoride. Acidulated Phosphate Fluoride should not be used for patients with porcelain, composite restorations and sealants.

leaflet_short:

2.73% sodium fluoride (1.23% fluoride ion) foam supplied in 4.4 fl.oz. aerosol container Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]

מצב אישור:

unapproved drug other

מאפייני מוצר

                                NUPRO 60 SECOND FLUORIDE FOAM- SODIUM FLUORIDE AEROSOL, FOAM
DENTSPLY PROFESSIONAL
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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NUPRO™
APF FLUORIDE FOAMS
RX ONLY
INDICATIONS AND USAGE
For topical application to aid in the protection against dental
caries.
DOSAGE AND ADMINISTRATION
Shake can thoroughly for at least 30 seconds before each use. Hold can
completely
upside down to dispense. Point can toward applicator tray and slowly
press nozzle to fill
tray. Use one press per arch (foam will expand slightly to fill the
tray). Dry tooth surface
and insert tray(s) in mouth. Have patient bite down for 1 minute or up
to 4 minutes.
Remove tray(s) and have patient expectorate excess. Instruct patient
not to eat, drink,
or rinse for 30 minutes.
RECOMMENDED FREQUENCY
Not to exceed 4 treatments per year.
CONTRAINDICATIONS
Hypersensitivity to fluoride. Acidulated Phosphate Fluoride should not
be used for
patients with porcelain, composite restorations and sealants.
PRECAUTIONS
DO NOT SWALLOW. KEEP OUT OF REACH OF CHILDREN.
Safety and effectiveness below 3 years of age has not been
established. There have
been no long term animal studies with this product to evaluate
carcinogenic, mutagenic,
or impairment of fertility potential. Laboratory studies have
indicated that repeated use
of Acidulated Phosphate Fluoride may dull porcelain, composite
restorations, and
sealants.
OVERDOSAGE
If treatment dose is swallowed (or less than 100 mg of Fluoride ion)
administer milk,
limewater, or calcium-type antacid. In case of larger doses swallowed
(more than 100
mg of Fluoride ion) administer ipecac syrup emetic and immediately
seek medical help.
Overdose symptoms include nausea, vomiting, diarrhea, and abdominal
pain.
ADVERSE REACTIONS
Developing teeth of children under 6 years of age may become
permanently discolored if
excessive amounts are repeatedly swallowed. The following adverse
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