SODIUM FLUORIDE 5000 PLUS- sodium fluoride cream

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Westminster Pharmaceuticals, LLC

Njia ya uendeshaji:

DENTAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 SF 5000 Plus brand of 1.1% sodium fluoride 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.

Bidhaa muhtasari:

1.8 oz. (51 g) net wt. tube Flavor: Spearmint NDC 69367-309-51 You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). Rx Only

Idhini hali ya:

unapproved drug other

Tabia za bidhaa

SODIUM FLUORIDE 5000 PLUS- SODIUM FLUORIDE CREAM
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._
----------
SF 5000 PLUS 1.1% SODIUM FLUORIDE - PRESCRIPTION DENTAL CREAM
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 INGREDIENTS: Sodium Fluoride USP 1.1% (w/w)
INACTIVE INGREDIENTS: FD&C Blue No. 1, glycerin, hydrated silica,
purified water,
sodium benzoate, sodium lauryl sulfate, sorbitol, spearmint flavor,
titanium dioxide,
xanthan gum, dicalcium phosphate, 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.
SF 5000 Plus brand of 1.1%
sodium fluoride 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 brushing
process without
significant swallowing. U