SODIUM FLUORIDE GEL- sodium fluoride gel, dentifrice

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

AvPAK

Stjórnsýsluleið:

DENTAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. Sodium Fluoride 1.1% Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.) Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Vörulýsing:

NET WT. 2 oz. (56g) tube containing light blue, mint flavored dental gel. NDC 50268-733-56 Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN TAMPER EVIDENT: Do not use if foil seal is missing or damaged. Rx Only

Leyfisstaða:

unapproved drug other

Vara einkenni

SODIUM FLUORIDE GEL- SODIUM FLUORIDE GEL, DENTIFRICE
AVPAK
_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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SODIUM FLUORIDE 1.1% GEL
1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL GEL
_SODIUM FLUORIDE 1.1% GEL _
_1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL GEL_
RX ONLY
DESCRIPTION
Self-topical neutral fluoride gel containing 1.1% (w/v) sodium
fluoride for use as a dental
caries preventive in pediatric patients and adults. This prescription
product is not a
dentifrice.
ACTIVE INGREDIENT
Sodium Fluoride 1.1% (w/v).
INACTIVE INGREDIENTS
FD&C Blue No. 1, glycerin, hydroxyethylcellulose, mint flavor,
purified water, sodium
benzoate, sodium saccharin, Sorbitol, xylitol.
CLINICAL PHARMACOLOGY
Frequent topical applications to the teeth with preparations having a
relatively high
fluoride content increase tooth resistance to acid dissolution and
enhance penetration of
the fluoride ion into tooth enamel.
INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use.
It is well established
that 1.1% sodium fluoride is safe and extraordinarily effective as a
caries preventive
when applied frequently with mouthpiece applicators. Sodium Fluoride
1.1% Gel in a
squeeze-tube is easily applied onto a toothbrush as well as a
mouthpiece tray. This
prescription dental gel should be used once daily following use of a
regular toothpaste
unless otherwise instructed by your dental professional. May be used
whether or not
drinking water is fluoridated since topical fluoride cannot produce
fluorosis. (See
WARNINGS for exception.)
CONTRAINDICATIONS
Do not use in pediatric patients under age 6 years unless recommended
by a dentist or
physician.
WARNINGS
Prolonged daily ingestion may result in various degrees of dental
fluorosis in pediatric
patients under 6 years,
especially if the water fluoridation exceeds 0.6 ppm, since younger
pediatric patients
frequently cannot perform t