PREVIDENT 5000 DRY MOUTH- sodium fluoride gel, dentifrice

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Colgate Oral Pharmaceuticals, Inc.

INN（国际名称）:

Sodium fluoride

组成:

fluoride ion 13.5 mg in 1 mL

给药途径:

DENTAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 Dry Mouth 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.

產品總結:

3.4 FL OZ (100 mL) in plastic bottles. Soothing Mint: NDC 0126-0016-61 Store at Controlled Room Temperature, 68-77°F (20-25°C)

授权状态:

unapproved drug other

产品特点

PREVIDENT 5000 DRY MOUTH- 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
5000
DRY MOUTH RX ONLY
_1.1% SODIUM FLUORIDE_
_Prescription Strength Toothpaste_
1
DESCRIPTION
Self-topical neutral fluoride toothpaste 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, propylene glycol, glycerin, PEG-40
hydrogenated castor
oil, dipotassium phosphate, poloxamer 407, flavor, PVM/MA copolymer,
xanthan gum,
sodium benzoate, sodium hydroxide, sodium saccharin, cocamidopropyl
betaine,
cetylpyridinium chloride, potassium sorbate, pectin, FD&C blue no. 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.
PreviDent
5000 Dry Mouth
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
®
®
_ppm_
1
_Formulated for Dry Mouth Sufferers_
1-4
®
in areas where 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