SODIUM FLUORIDE 5000 PPM DRY MOUTH- sodium fluoride gel, dentifrice

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Sheffield Pharmaceuticals LLC

Vartojimo būdas:

DENTAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 ppm Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube 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.

Produkto santrauka:

HOW SUPLLIED                                                                           3.4 FL OZ (100 mL) tube                                                 NDC  11527-755-34 Store at Controlled Room Temperature, 68-77°F (20-25°C)

Autorizacija statusas:

unapproved drug other

Prekės savybės

SODIUM FLUORIDE 5000 PPM DRY MOUTH- SODIUM FLUORIDE GEL, DENTIFRICE
SHEFFIELD 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._
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SODIUM FLUORIDE 5000 PPM DRY MOUTH
SODIUM FLUORIDE 5000 PPM DRY MOUTH
DESCRIPTION:
Self-topical neutral fluoride toothpaste 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:
water, sorbitol, hydrated silica, propylene glycol, glycerin, PEG-40
hydrogenated castor
oil, poloxamer 407, xanthan gum, PVM/MA copolymer, flavor,
cocamidopropyl betaine,
sodium saccharin, dipotassium phospate, sodium hydroxide, sodium
benzoate,
potassium sorbate, cetylpyridinium chloride, 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.
Sodium Fluoride 5000 ppm Dry
Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube 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.)
CONTRAINDICATIONS:
1-4
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