SODIUM FLUORIDE 5000 PLUS- sodium fluoride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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 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.

Product summary:

NDC: 63629-1151-1 51 grams in a BOTTLE

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM FLUORIDE 5000 PLUS- SODIUM FLUORIDE CREAM
BRYANT RANCH PREPACK
_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 PLUS
SODIUM FLUORIDE 5000 PLUS - 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL
CREAM
METHOD 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._
----------
SODIUM FLUORIDE 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, sodium saccharin, sorbitol, spearmint
flavor, tetrasodium
pyrophosphate, titanium dioxide, xanthan gum.
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 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 u