DENTA 5000 PLUS- sodium fluoride gel, dentifrice

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
28-12-2021

Bahan aktif:

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

Tersedia dari:

Rising Pharmaceuticals, Inc.

INN (Nama Internasional):

SODIUM FLUORIDE

Komposisi:

SODIUM FLUORIDE 1.1 g in 100 g

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 Denta 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 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.

Ringkasan produk:

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

Status otorisasi:

unapproved drug other

Karakteristik produk

                                DENTA 5000 PLUS - SODIUM FLUORIDE GEL, DENTIFRICE
RISING 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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DENTA 5000 PLUS
BRAND OF 1.1% SODIUM FLUORIDE
PRESCRIPTION DENTAL CREAM
DENTA 5000 PLUS BRAND OF 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 preventative in adults and pediatric patients.
ACTIVE INGREDIENT:
Sodium Fluoride 1.1% (w/w)
INACTIVE INGREDIENTS:
Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium
Pyrophosphate, Flavor, PEG
12, Sodium Lauryl Sulfate, Carboxymethylcellulose Gum, Sodium
Saccharin, Titanium
Dioxide, FD&C Blue #1
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.
Denta 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 in areas
where drinking
water is fluoridated, since topical fluoride cannot produce fluorosis.
(See WARNINGS for
exception.)
1-4
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
                                
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