SODIUM FLOURIDE- sodium fluoride paste, dentifrice

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AvKARE

Via de administração:

DENTAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.1-4 Sodium Fluoride 1.1% in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your 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.

Resumo do produto:

1.8 oz. (51 g) net wt. tube NDC# 42291-741-51 Store at controlled room temperature 20° - 25°C (68°-77°F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN Rx Only

Status de autorização:

unapproved drug other

Características técnicas

SODIUM FLOURIDE- SODIUM FLUORIDE PASTE, DENTIFRICE
AVKARE
_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 FLOURIDE 1.1%
1.1% SODIUM FLOURIDE PRESCRIPTION DENTAL TOOTHPASTE
_SODIUM FLUORIDE 1.1%_
_1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL TOOTHPASTE_
DESCRIPTION
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium
fluoride for use as a
dental caries preventive in adults and pediatric patients.
ACTIVE INGREDIENT
Sodium fluoride 1.1% (w/w).
INACTIVE INGREDIENTS
Dicalcium Phosphate, FD&C Blue No. 1, Flavor, Glycerin, Hydrated
Silica, Purified Water,
Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Spearmint Flavor,
Titanium Dioxide,
Xanthan Gum, 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.1-4 Sodium
Fluoride 1.1% in a squeeze-tube is easily applied onto a toothbrush.
This prescription
dental cream should
be used once daily in place of your 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 age 6 years,
especially if the water fluoridation exceeds 0.6 ppm, since younger
pediatric patients
frequently cannot perform the
bru