PREVIDENT 5000 BOOSTER PLUS SPEARMINT- sodium fluoride paste, dentifrice

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Colgate Oral Pharmaceuticals, Inc.

INN (International Adı):

Sodium Fluoride

Kompozisyon:

Fluoride Ion 6 mg in 1 mL

Uygulama yolu:

DENTAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste 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.

Ürün özeti:

3.4 FL OZ (100mL) in plastic bottles. Spearmint: NDC 0126-0074-92 Store at Controlled Room Temperature, 68-77°F (20-25°C)

Yetkilendirme durumu:

unapproved drug other

Ürün özellikleri

PREVIDENT 5000 BOOSTER PLUS SPEARMINT- SODIUM FLUORIDE PASTE,
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._
----------
COLGATE
PREVIDENT 5000 PPM
BOOSTERPLUS
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
fumaric acid, hydrated silica, mica, PEG-12, poloxamer 338, sodium
benzoate, sodium
carboxymethylcellulose, sodium lauryl sulfate, sodium saccharin,
sorbitol, titanium
dioxide, tricalcium phosphate, water, xanthan gum. This product also
contains flavor,
FD&C Blue No. 1 (Spearmint only), D&C Red No. 33 (Fruitastic 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® 5000 BoosterPlus
brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily
applied onto a
toothbrush. This prescription toothpaste 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 deg