PREVIDENT FRESH MINT- sodium fluoride gel, dentifrice PREVIDENT VERY BERRY- sodium fluoride gel, dentifrice

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)

Tillgänglig från:

Colgate Oral Pharmaceuticals, Inc.

INN (International namn):

Sodium Fluoride

Sammansättning:

Fluoride Ion 5 mg in 1 g

Administreringssätt:

DENTAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 PreviDent® 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. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Produktsammanfattning:

Store at controlled room temperature, 68-77°F (20-25°C).

Bemyndigande status:

unapproved drug other

Produktens egenskaper

PREVIDENT FRESH MINT- SODIUM FLUORIDE GEL, DENTIFRICE
PREVIDENT VERY BERRY- SODIUM FLUORIDE GEL, DENTIFRICE
COLGATE ORAL PHARMACEUTICALS, INC.
_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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COLGATE
PREVIDENT
GEL
_1.1% SODIUM FLUORIDE_
RX ONLY
DESCRIPTION
Self-topical neutral fluoride gel containing 1.1% 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
Cetylpyridinium chloride, flavor, hydroxyethycellulose, poloxamer 407,
sodium
saccharin, sorbitol, titanium dioxide, water, FD&C blue no. 1
(FreshMint only), FD&C red
no. 40 (Very Berry 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.
PreviDent® 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.
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 in the areas with high fluoride
concentration in
drinking water. Use in pediatric patients under age 6 years requires
special supervision
to prevent repeated swallowing of gel. Read directions car