SODIUM FLUORIDE 5000 PPM- sodium fluoride paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 5000 ppm 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used in areas where 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.

Product summary:

Store at Controlled Room Temperature, 20°-25°C (68°-77°F).

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM FLUORIDE 5000 PPM- SODIUM FLUORIDE PASTE
WESTMINSTER PHARMACEUTICALS, LLC
_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 5000 PPM
Rx Only
_1.1% SODIUM FLUORIDE_
_Prescription Strength 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, flavor, glycerin, hydrated silica, purified
water, sodium benzoate,
sodium lauryl sulfate, sorbitol, titanium dioxide, xanthan gum,
xylitol. This product also
contains flavor, FD&C blue No. 1 (Spearmint only), FD&C red No. 40
(Fruity only).
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 5000 ppm
1.1% sodium fluoride in a squeeze-tube is easily applied onto a
toothbrush. This
prescription should be used once daily in place of your regular
toothpaste, unless
otherwise instructed by your dental professional. May be used in areas
where 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
1-4
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